FDA · Medical device recall

REALIZE Adjustable Gastric Band… and 15 more products

Nov. 2, 2010

Date posted by the FDA: Nov. 2, 2010
Status: Terminated
Filed by: Ethicon Endo-Surgery Inc
Reason: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
Distribution pattern: Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.

16 products in this recall

REALIZE Adjustable Gastric Band…

Product: REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3, ZJBBBG, ZJBBBH, ZJBBBK, ZJBBCF, ZJBBCG, ZJBBCH, ZJBBCJ, ZJBBD6, ZJBBD7, ZJBBD8, ZJBBD9, ZJBBDH, ZJBBDJ, ZJBBDK, ZJBBFB, ZJBBFC, ZJCBBT, ZJCBBV, ZJCBBW, ZJCBDL, ZJCBDM, ZJCBDN, ZJDBBL, ZJDBDY, ZJFBBB, ZJFBBC, ZJFBBD, ZJFBDC, ZJFBDD, ZJFBF0, ZJFBF1, ZJFBF2, ZJFBKH, ZJFBMK, ZJGBCC, ZJGBCD, ZJGBGM, ZJGBHJ, ZJGBHK, ZJGBTT, ZJHBCD, ZJHBCF, ZJHBCG, ZJHBF5, ZJHBF6, ZJHBF7, ZJHBK8, ZJHBK9, ZJHBLB, ZJHBLC, ZJHBLD, ZJHBLF, ZJJBC4, ZJJBC5, ZJJBC6, ZJJBF9, ZJJBGB, ZJJBGC, ZJJBHM, ZJJBHN, ZJJBHP, ZJJBHR, ZJJBLK, ZJJBLL, ZJJBNV, ZJJBNW, ZJKBBB, ZJKBBC, ZJKBBD, ZJKBC2, ZJKBC3, ZJKBC4, ZJKBHD, ZJKBK4, ZJKBK5, ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7 & ZLFBFB.
Quantity: 23,538 pieces
Codes and lots: Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3, ZJBBBG, ZJBBBH, ZJBBBK, ZJBBCF, ZJBBCG, ZJBBCH, ZJBBCJ, ZJBBD6, ZJBBD7, ZJBBD8, ZJBBD9, ZJBBDH, ZJBBDJ, ZJBBDK, ZJBBFB, ZJBBFC, ZJCBBT, ZJCBBV, ZJCBBW, ZJCBDL, ZJCBDM, ZJCBDN, ZJDBBL, ZJDBDY, ZJFBBB, ZJFBBC, ZJFBBD, ZJFBDC, ZJFBDD, ZJFBF0, ZJFBF1, ZJFBF2, ZJFBKH, ZJFBMK, ZJGBCC, ZJGBCD, ZJGBGM, ZJGBHJ, ZJGBHK, ZJGBTT, ZJHBCD, ZJHBCF, ZJHBCG, ZJHBF5, ZJHBF6, ZJHBF7, ZJHBK8, ZJHBK9, ZJHBLB, ZJHBLC, ZJHBLD, ZJHBLF, ZJJBC4, ZJJBC5, ZJJBC6, ZJJBF9, ZJJBGB, ZJJBGC, ZJJBHM, ZJJBHN, ZJJBHP, ZJJBHR, ZJJBLK, ZJJBLL, ZJJBNV, ZJJBNW, ZJKBBB, ZJKBBC, ZJKBBD, ZJKBC2, ZJKBC3, ZJKBC4, ZJKBHD, ZJKBK4, ZJKBK5, ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7 & ZLFBFB.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0289-2011

REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T…

Product: REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #: G4RE82
Codes and lots: Product Code RLZB22T, Lot #: G4RE82
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0290-2011

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1…

Product: REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK21, G4TL1D, G4TM3L, G4TM84, , , G4TP0W, G4TT4D, G4TU2V, G4TV3T & G4TW6D.
Quantity: 383 pieces
Codes and lots: Product Code RLZB22T, Lot #: G4RE82Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK21, G4TL1D, G4TM3L, G4TM84 , G4TP0W, G4TT4D, G4TU2V, G4TV3T & G4TW6D.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0291-2011

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB22DT…

Product: REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C
Codes and lots: Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0292-2011

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB22DG1…

Product: REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V
Quantity: 105 pieces
Codes and lots: Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0293-2011

REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector…

Product: REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar Product Code RLZB22DGT, Lot #: G4RK0E
Quantity: 1 piece
Codes and lots: Product Code RLZB22DGT, Lot #: G4RK0E
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0294-2011

REALIZE Adjustable Gastric Band-C Product Code RLZB32…

Product: REALIZE Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMBRB, ZJNBB6, ZJNBB7, ZJNBB8, ZJNBB9, ZJNBF5, ZJNBGM, ZJNBGN, ZJNBGP, ZJNBGR, ZJNBK4, ZJNBK5, ZJNBNH, ZJPBF3, ZKBBB8, ZKBBB9, ZKBBCB, ZKBBCM, ZKBBGF, ZKBBGG, ZKBBGH, ZKBBJR, ZKBBJT, ZKBBL0, ZKBBL1, ZKBBL2, ZKBBLY, ZKBBLZ, ZKBBMT, ZKBBN0, ZKBBNZ, ZKCBBH, ZKCBBJ, ZKCBC8, ZKCBC9, ZKCBDY, ZKCBHY, ZKCBHZ, ZKCBKK, ZKCBKL, ZKCBKM, ZKDB05, ZKDB06, ZKDB07, ZKDB08, ZKDB0D, ZKDB0F, ZKDB0G, ZKDBLY, ZKDBLZ, ZKDBMC, ZKDBMD, ZKDBMF, ZKDBMG, ZKDBMH, ZKFBB4, ZKFBBB, ZKFBBF, ZKFBC8, ZKFBC9, ZKFBCL, ZKFBCV, ZKFBDD, ZKFBFH, ZKFBFJ, ZKGBBN, ZKGBBP, ZKGBBR, ZKGBCK, ZKGBCL, ZKGBCM, ZKGBDM, ZKGBDN, ZKGBDP, ZKGBFF, ZKHBBC, ZKHBCH, ZKJBC4, ZKJBCK, ZKJBCL, ZKJBDM, ZKJBDN, ZKJBFV, ZKJBG3, ZKJBGK, ZKJBGL, ZKJBHY, ZKJBHZ, ZKKBB2, ZKKBB3, ZKKBBD, ZKKBBF, ZKKBC6, ZKKBC7, ZKKBD2, ZKKBD3, ZKLBBK, ZKLBBL, ZKLBBM, ZKLBC7, ZKLBCB, ZKLBCC, ZKLBCG, ZKLBCH, ZKLBCJ, ZKLBCK, ZKMBBL, ZKMBBM, ZKMBBN, ZKMBBP, ZKMBKJ, ZKMBKK, ZKMBKL, ZKMBKV, ZKMBKW, ZKMBKY, ZKMBKZ, ZKMBMC, ZKMBMD, ZKMBMF, ZKMBMG, ZKMBMH, ZKMBMJ, ZKMBP4, ZKMBP5, ZKMBP6, ZKMBP7, ZKMBRP, ZKNBBJ, ZKNBBK, ZKNBBL, ZKNBCV, ZKNBCW, ZKNBCY, ZKNBFC, ZKNBG0, ZKNBGM, ZKNBGN, ZKNBGP, ZKNBHH, ZKNBHJ, ZLBBBB, ZLBBBK, ZLBBBL, ZLBBCL, ZLBBDP, ZLBBFN, ZLBBFP, ZLCBBD, ZLCBBF, ZLCBC8, ZLCBCF, ZLCBCG, ZLCBFC, ZLCBGC, ZLDBBF, ZLDBBG, ZLDBBH, ZLDBBJ, ZLDBBK, ZLDBC1, ZLDBC2, ZLDBCC, ZLDBCD, ZLDBCF, ZLDBCG, ZLDBDW, ZLDBDY, ZLFBBJ, ZLFBBK, ZLFBBL, ZLFBCN, ZLFBFC, ZLFBFD, ZLFBGN, ZLFBGP, ZLGBCG, ZLGBCH, ZLGBDD, ZLGBF2, ZLGBF3, ZLGBHC, ZLGBHD, ZLHBBM, ZLHBBN, ZLHBDN, ZLHBDW, ZLHBDY, ZLHBF1, ZLJBBC, ZLJBBV, ZLJBCV & ZLJBCW.
Quantity: 33,599 pieces
Codes and lots: Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMBRB, ZJNBB6, ZJNBB7, ZJNBB8, ZJNBB9, ZJNBF5, ZJNBGM, ZJNBGN, ZJNBGP, ZJNBGR, ZJNBK4, ZJNBK5, ZJNBNH, ZJPBF3, ZKBBB8, ZKBBB9, ZKBBCB, ZKBBCM, ZKBBGF, ZKBBGG, ZKBBGH, ZKBBJR, ZKBBJT, ZKBBL0, ZKBBL1, ZKBBL2, ZKBBLY, ZKBBLZ, ZKBBMT, ZKBBN0, ZKBBNZ, ZKCBBH, ZKCBBJ, ZKCBC8, ZKCBC9, ZKCBDY, ZKCBHY, ZKCBHZ, ZKCBKK, ZKCBKL, ZKCBKM, ZKDB05, ZKDB06, ZKDB07, ZKDB08, ZKDB0D, ZKDB0F, ZKDB0G, ZKDBLY, ZKDBLZ, ZKDBMC, ZKDBMD, ZKDBMF, ZKDBMG, ZKDBMH, ZKFBB4, ZKFBBB, ZKFBBF, ZKFBC8, ZKFBC9, ZKFBCL, ZKFBCV, ZKFBDD, ZKFBFH, ZKFBFJ, ZKGBBN, ZKGBBP, ZKGBBR, ZKGBCK, ZKGBCL, ZKGBCM, ZKGBDM, ZKGBDN, ZKGBDP, ZKGBFF, ZKHBBC, ZKHBCH, ZKJBC4, ZKJBCK, ZKJBCL, ZKJBDM, ZKJBDN, ZKJBFV, ZKJBG3, ZKJBGK, ZKJBGL, ZKJBHY, ZKJBHZ, ZKKBB2, ZKKBB3, ZKKBBD, ZKKBBF, ZKKBC6, ZKKBC7, ZKKBD2, ZKKBD3, ZKLBBK, ZKLBBL, ZKLBBM, ZKLBC7, ZKLBCB, ZKLBCC, ZKLBCG, ZKLBCH, ZKLBCJ, ZKLBCK, ZKMBBL, ZKMBBM, ZKMBBN, ZKMBBP, ZKMBKJ, ZKMBKK, ZKMBKL, ZKMBKV, ZKMBKW, ZKMBKY, ZKMBKZ, ZKMBMC, ZKMBMD, ZKMBMF, ZKMBMG, ZKMBMH, ZKMBMJ, ZKMBP4, ZKMBP5, ZKMBP6, ZKMBP7, ZKMBRP, ZKNBBJ, ZKNBBK, ZKNBBL, ZKNBCV, ZKNBCW, ZKNBCY, ZKNBFC, ZKNBG0, ZKNBGM, ZKNBGN, ZKNBGP, ZKNBHH, ZKNBHJ, ZLBBBB, ZLBBBK, ZLBBBL, ZLBBCL, ZLBBDP, ZLBBFN, ZLBBFP, ZLCBBD, ZLCBBF, ZLCBC8, ZLCBCF, ZLCBCG, ZLCBFC, ZLCBGC, ZLDBBF, ZLDBBG, ZLDBBH, ZLDBBJ, ZLDBBK, ZLDBC1, ZLDBC2, ZLDBCC, ZLDBCD, ZLDBCF, ZLDBCG, ZLDBDW, ZLDBDY, ZLFBBJ, ZLFBBK, ZLFBBL, ZLFBCN, ZLFBFC, ZLFBFD, ZLFBGN, ZLFBGP, ZLGBCG, ZLGBCH, ZLGBDD, ZLGBF2, ZLGBF3, ZLGBHC, ZLGBHD, ZLHBBM, ZLHBBN, ZLHBDN, ZLHBDW, ZLHBDY, ZLHBF1, ZLJBBC, ZLJBBV, ZLJBCV & ZLJBCW.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0295-2011

REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T…

Product: REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T, Lot #: G4RK3F, G4RK51, G4RM62, G4RR1P, G4RW4H, G4RZ07, G4T01F, G4T290, G4T299, G4T525 & G4T821.
Quantity: 108 pieces
Codes and lots: Product Code RLZB32T, Lot #: G4RK3F, G4RK51, G4RM62, G4RR1P, G4RW4H, G4RZ07, G4T01F, G4T290, G4T299, G4T525 & G4T821.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0296-2011

REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB32DT…

Product: REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB32DT, Lot #: G4RL1U, G4RL9A, G4RM2V, G4RM5T, G4RN6P, G4RP1M, G4RR5G, G4RW0R & G4TR72.
Quantity: 258 pieces
Codes and lots: Product Code RLZB32DT, Lot #: G4RL1U, G4RL9A, G4RM2V, G4RM5T, G4RN6P, G4RP1M, G4RR5G, G4RW0R & G4TR72.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0297-2011

REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube…

Product: REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube. Product Code RLZB32DG1, Lot #: G4RK2R, G4RN94, G4RW06, G4RY5C, G4T160, G4T26C, G4T31A, G4T402, G4T46F, G4T695, G4T80A, G4T95G, G4TE9K, G4TF7K, G4TJ0A, G4TJ6Z, G4TL16, G4TM2E, G4TM9K, G4TN3J, G4TN7X, G4TP91, G4TT4N, G4TU84, G4TV1X & G4TV7C.
Quantity: 505 pieces
Codes and lots: Product Code RLZB32DG1, Lot #: G4RK2R, G4RN94, G4RW06, G4RY5C, G4T160, G4T26C, G4T31A, G4T402, G4T46F, G4T695, G4T80A, G4T95G, G4TE9K, G4TF7K, G4TJ0A, G4TJ6Z, G4TL16, G4TM2E, G4TM9K, G4TN3J, G4TN7X, G4TP91, G4TT4N, G4TU84, G4TV1X & G4TV7C.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0298-2011

REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector…

Product: REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar. Product Code RLZB32DGT, Lot #: G4RE81, G4RK6N, G4RL6Z, G4T824, G4T98X, G4TN3R, G4TP1A & G4TR4J.
Quantity: 138 pieces
Codes and lots: Product Code RLZB32DGT, Lot #: G4RE81, G4RK6N, G4RL6Z, G4T824, G4T98X, G4TN3R, G4TP1A & G4TR4J.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0299-2011

REALIZE Adjustable Gastric Band-C with Endoscopic Dissector…

Product: REALIZE Adjustable Gastric Band-C with Endoscopic Dissector. Product Code RLZB32D1, Lot #: G4RK0M, G4RL9X, G4RM94, G4RN9G, G4RY2M, G4RY3E, G4RY56, G4T00G, G4T137, G4T15H, G4T202, G4T224, G4T26M, G4T27Z, G4T31N, G4T31V, G4T34N, G4T385, G4T42F, G4T43U, G4T52W, G4T56F, G4T68L, G4T74D, G4T87X, G4T95Y, G4T992, G4TA5Y, G4TA8W, G4TC20, G4TC48, G4TD1C, G4TD20, G4TE10, G4TE17, G4TE7M, G4TE87, G4TE9Z, G4TF0C, G4TF7A, G4TF9M, G4TG25, G4TG5A, G4TH1V, G4TH48, G4TJ3F, G4TJ70, G4TK18, G4TK1K, G4TK69, G4TK6G, G4TK6T, G4TK90, G4TK9D, G4TL1U, G4TL21, G4TL4C, G4TL58, G4TL6Z, G4TL79, G4TL7H, G4TL7V, G4TM2M, G4TM5K, G4TM5N, G4TM66, G4TM6N, G4TM8A, G4TN16, G4TN86, G4TP15, G4TP39, G4TP3N, G4TP6U, G4TP77, G4TP93, G4TP9K, G4TR22, G4TR4R, G4TR5E, G4TV69, G4TV6N, G4TW45, G4TW67, G4TX6A, G4TX8C & G4TY13.
Quantity: 3,623 pieces
Codes and lots: Product Code RLZB32D1, Lot #: G4RK0M, G4RL9X, G4RM94, G4RN9G, G4RY2M, G4RY3E, G4RY56, G4T00G, G4T137, G4T15H, G4T202, G4T224, G4T26M, G4T27Z, G4T31N, G4T31V, G4T34N, G4T385, G4T42F, G4T43U, G4T52W, G4T56F, G4T68L, G4T74D, G4T87X, G4T95Y, G4T992, G4TA5Y, G4TA8W, G4TC20, G4TC48, G4TD1C, G4TD20, G4TE10, G4TE17, G4TE7M, G4TE87, G4TE9Z, G4TF0C, G4TF7A, G4TF9M, G4TG25, G4TG5A, G4TH1V, G4TH48, G4TJ3F, G4TJ70, G4TK18, G4TK1K, G4TK69, G4TK6G, G4TK6T, G4TK90, G4TK9D, G4TL1U, G4TL21, G4TL4C, G4TL58, G4TL6Z, G4TL79, G4TL7H, G4TL7V, G4TM2M, G4TM5K, G4TM5N, G4TM66, G4TM6N, G4TM8A, G4TN16, G4TN86, G4TP15, G4TP39, G4TP3N, G4TP6U, G4TP77, G4TP93, G4TP9K, G4TR22, G4TR4R, G4TR5E, G4TV69, G4TV6N, G4TW45, G4TW67, G4TX6A, G4TX8C & G4TY13.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0300-2011

REALIZE Injection Port and Applier…

Product: REALIZE Injection Port and Applier. Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD, ZJBBBY, ZJCBB0, ZJCBBH, ZJCBDR, ZJJBMT, ZJKBCY, ZJMBPB, ZJNBB4, ZJNBBJ, ZJPBB5, ZKBBCJ, ZKBBGP, ZKBBLM, ZKCBDZ, ZKCBJH, ZKDBK9, ZKDBM2, ZKDBMT, ZKFBC6, ZKFBCW, ZKFBCZ, ZKFBDF, ZKFBFK, ZKMBKR, ZKMBN1, ZKMBP2, ZKNBBF, ZKNBFB, ZKNBHG, ZLCBC7, ZLCBG9, ZLDBBD, ZLDBDZ, ZLFBCJ, ZLFBGR, ZLGBCB, ZLGBDG, ZLGBHF, ZLHBF3 & ZLJBD1.
Quantity: 2,008 pieces
Codes and lots: Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD, ZJBBBY, ZJCBB0, ZJCBBH, ZJCBDR, ZJJBMT, ZJKBCY, ZJMBPB, ZJNBB4, ZJNBBJ, ZJPBB5, ZKBBCJ, ZKBBGP, ZKBBLM, ZKCBDZ, ZKCBJH, ZKDBK9, ZKDBM2, ZKDBMT, ZKFBC6, ZKFBCW, ZKFBCZ, ZKFBDF, ZKFBFK, ZKMBKR, ZKMBN1, ZKMBP2, ZKNBBF, ZKNBFB, ZKNBHG, ZLCBC7, ZLCBG9, ZLDBBD, ZLDBDZ, ZLFBCJ, ZLFBGR, ZLGBCB, ZLGBDG, ZLGBHF, ZLHBF3 & ZLJBD1.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0301-2011

SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier…

Product: SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier. Product Code BD2XV, Lot #: 1040602, , 1040603, , 10270503, , 11020504, , 11030502, , 11090510, , 11090511, 1090512, 12030502, 12070502, 12070503, 12070504, 12200501, 12200502, 12200503, 12290505, 12290506, 01120603, 01200602, 01260601, 01260602, 01260603, 01260604, 02210605, 02210606, 02210607, 02280622, 02280623, 03080601, 03080602, 03080605, 03220611, 03220612, 05150601, 05150602, 05150603, 05150604, 05300613, 05300614, 06190606, 06190607, 06190608, 06190614, 06190615, 06190616, 06190617, 06190618, 06260601, 07060601, 07100605, 08140607, 08140608, 09050601, 09050602, 09050603, 09050604, 09050605, 09130601, 09130602, 09130603, 09130604, 09130605, 09180602, 09180603, 09180604, 09250602, 10110601, 10110602, 10110603, 20002024, 20002082, 20002185, 20002186, 20002193, 20002438, 20002439, 20002440, 20002441, 20002484, 20002485, 20003152, 20003153, 20003154, 20003155, 20003196, 20003362, 20003363, 20004437, 20004438, 20005244, 20005659, 20006819, 20006921, ZGNB43, ZGNB44, ZGNB45, ZGPBCC, ZGPBCD, ZGPBCJ, ZGPBCK, ZHBBBN, ZHBBBP, ZHBBBT, ZHCBB0, ZHCBB1, ZHCBB2, ZHCBB3, ZHCBB5, ZHCBB6, ZHCBB7, ZHCBB8, ZHCBB9, ZHDBF7, ZHFB76, ZHFB77, ZHFB79, ZHFBBW, ZHFBBY, ZHGBBJ, ZHGBDJ, ZHGBDK, ZHGBDL, ZHHBD6, ZHHBD7, ZHHBD8, ZHHBD9, ZHHBFB, ZHHBFC, ZHJBBJ, ZHJBBK, ZHJBBL, ZHJBBM, ZHJBBN, ZHJBBP, ZHMBDP, ZHNBC1, ZHNBC2, ZHPBBT, ZJBBBF, ZJBBDP, ZJCBB6, ZJCBDP, ZJCBGL, ZJDBBD, ZJDBBF, ZJDBBG, ZJDBBH, ZJDBBJ, ZJDBBK, ZJFBL6, ZJFBML, ZJHBCH, ZJHBK7, ZJJBC3, ZJKBC1, ZJKBHC, ZJKBK2, ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKFBDH, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV & ZLGBG5.
Quantity: 26,966 pieces
Codes and lots: Product Code BD2XV, Lot #: 1040602 1040603 10270503 11020504 11030502 11090510 11090511, 1090512, 12030502, 12070502, 12070503, 12070504, 12200501, 12200502, 12200503, 12290505, 12290506, 01120603, 01200602, 01260601, 01260602, 01260603, 01260604, 02210605, 02210606, 02210607, 02280622, 02280623, 03080601, 03080602, 03080605, 03220611, 03220612, 05150601, 05150602, 05150603, 05150604, 05300613, 05300614, 06190606, 06190607, 06190608, 06190614, 06190615, 06190616, 06190617, 06190618, 06260601, 07060601, 07100605, 08140607, 08140608, 09050601, 09050602, 09050603, 09050604, 09050605, 09130601, 09130602, 09130603, 09130604, 09130605, 09180602, 09180603, 09180604, 09250602, 10110601, 10110602, 10110603, 20002024, 20002082, 20002185, 20002186, 20002193, 20002438, 20002439, 20002440, 20002441, 20002484, 20002485, 20003152, 20003153, 20003154, 20003155, 20003196, 20003362, 20003363, 20004437, 20004438, 20005244, 20005659, 20006819, 20006921, ZGNB43, ZGNB44, ZGNB45, ZGPBCC, ZGPBCD, ZGPBCJ, ZGPBCK, ZHBBBN, ZHBBBP, ZHBBBT, ZHCBB0, ZHCBB1, ZHCBB2, ZHCBB3, ZHCBB5, ZHCBB6, ZHCBB7, ZHCBB8, ZHCBB9, ZHDBF7, ZHFB76, ZHFB77, ZHFB79, ZHFBBW, ZHFBBY, ZHGBBJ, ZHGBDJ, ZHGBDK, ZHGBDL, ZHHBD6, ZHHBD7, ZHHBD8, ZHHBD9, ZHHBFB, ZHHBFC, ZHJBBJ, ZHJBBK, ZHJBBL, ZHJBBM, ZHJBBN, ZHJBBP, ZHMBDP, ZHNBC1, ZHNBC2, ZHPBBT, ZJBBBF, ZJBBDP, ZJCBB6, ZJCBDP, ZJCBGL, ZJDBBD, ZJDBBF, ZJDBBG, ZJDBBH, ZJDBBJ, ZJDBBK, ZJFBL6, ZJFBML, ZJHBCH, ZJHBK7, ZJJBC3, ZJKBC1, ZJKBHC, ZJKBK2, ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKFBDH, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV & ZLGBG5.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0302-2011

SAGB VC Swedish Adjustable Gastric Band including Velocity" Injection Port Applier Product Code BD3XV…

Product: SAGB VC Swedish Adjustable Gastric Band including Velocity" Injection Port Applier Product Code BD3XV, Lot #: 20008640, 20008641, 20008642, 20019968, 20019969, 20019975, 20019976, 20020378, 20024091, 20027139, 20027140, 20027141, 20027142, 20027143, 20028312, 20028313, 20028314, 20028315, 20047060, 20047061, 20051432, 20052462, 20052463, 20052464, 20052465, 20061807, 20061808, 20061809, 20067417, 20072957, 20072958, 20072960, 20072961, 20072962, 20074075, 20074077, 20074078, 20074079, 20074681, 20086611, 20093420, 20093421, 20095603, 20095604, 20095605, 20095607, 20095662, 20095663, 20095889, 20099522, 20099523, 20099590, 20099591, 20099600, 20099601, 20106185, 20106186, 20106187, 20106188, 20113097, 20121631, 20125349, 20148010, 20148011, 20148012, 20148013, 20148014, 20148015, 20148016, 20148017, 20148018, 20148019, 20148020, 20148021, 20148022, 20148023, 20148024, 20150225, 20150226, 20150227, 20204442, 20204443, 20209202, 20216977, 20216978, 20217032, 20217033, 20217034, 20217035, 20220032, 20220033, 20227517, 20227518, 20227519, 20227520, 20227521, ZJLBB3, ZJNBB5, ZJNBGK, ZJNBGL, ZJNBKY, ZJNBKZ, ZKBBCH, ZKBBGN, ZKBBLP, ZKBBLR, ZKBBLT, ZKBBLV, ZKBBLW, ZKBBMG, ZKBBMH, ZKCBBM, ZKFBCD, ZKFBDN, ZKFBFL, ZKHBBG, ZKHBC6, ZKHBC7, ZKHBCL, ZKJBCH, ZKJBCJ, ZKJBDK, ZKJBDL, ZKJBFK, ZKJBFL, ZKKBCH, ZKKBCV, ZKKBD1, ZKKBDT, ZKKBDV, ZKLBBG, ZKLBCF, ZKLBD2, ZKLBD3, ZKMBJT, ZKMBJV, ZKMBRN, ZKNBBG, ZKNBBH, ZKNBCT, ZKNBD8, ZKNBD9, ZKNBGL, ZKNBHB, ZLDBDN, ZLFBBD, ZLFBBF, ZLFBCK, ZLFBCL, ZLFBD5, ZLFBD6, ZLFBD7, ZLFBGH, ZLFBGJ, ZLGBB9, ZLGBC7, ZLGBC8, ZLGBFW, ZLGBFY, ZLGBG2, ZLGBG6, ZLGBG7, ZLHBBC, ZLHBBD, ZLHBBF, ZLHBCM, ZLHBCN, ZLHBDR, ZLHBDT, ZLHBF0 & ZLJBBB.
Quantity: 33,378 pieces
Codes and lots: Product Code BD2XV, Lot #: 1040602 1040603 10270503 11020504 11030502 11090510 11090511, 1090512, 12030502, 12070502, 12070503, 12070504, 12200501, 12200502, 12200503, 12290505, 12290506, 01120603, 01200602, 01260601, 01260602, 01260603, 01260604, 02210605, 02210606, 02210607, 02280622, 02280623, 03080601, 03080602, 03080605, 03220611, 03220612, 05150601, 05150602, 05150603, 05150604, 05300613, 05300614, 06190606, 06190607, 06190608, 06190614, 06190615, 06190616, 06190617, 06190618, 06260601, 07060601, 07100605, 08140607, 08140608, 09050601, 09050602, 09050603, 09050604, 09050605, 09130601, 09130602, 09130603, 09130604, 09130605, 09180602, 09180603, 09180604, 09250602, 10110601, 10110602, 10110603, 20002024, 20002082, 20002185, 20002186, 20002193, 20002438, 20002439, 20002440, 20002441, 20002484, 20002485, 20003152, 20003153, 20003154, 20003155, 20003196, 20003362, 20003363, 20004437, 20004438, 20005244, 20005659, 20006819, 20006921, ZGNB43, ZGNB44, ZGNB45, ZGPBCC, ZGPBCD, ZGPBCJ, ZGPBCK, ZHBBBN, ZHBBBP, ZHBBBT, ZHCBB0, ZHCBB1, ZHCBB2, ZHCBB3, ZHCBB5, ZHCBB6, ZHCBB7, ZHCBB8, ZHCBB9, ZHDBF7, ZHFB76, ZHFB77, ZHFB79, ZHFBBW, ZHFBBY, ZHGBBJ, ZHGBDJ, ZHGBDK, ZHGBDL, ZHHBD6, ZHHBD7, ZHHBD8, ZHHBD9, ZHHBFB, ZHHBFC, ZHJBBJ, ZHJBBK, ZHJBBL, ZHJBBM, ZHJBBN, ZHJBBP, ZHMBDP, ZHNBC1, ZHNBC2, ZHPBBT, ZJBBBF, ZJBBDP, ZJCBB6, ZJCBDP, ZJCBGL, ZJDBBD, ZJDBBF, ZJDBBG, ZJDBBH, ZJDBBJ, ZJDBBK, ZJFBL6, ZJFBML, ZJHBCH, ZJHBK7, ZJJBC3, ZJKBC1, ZJKBHC, ZJKBK2, ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKFBDH, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV & ZLGBG5.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0303-2011

Velocity" Injection Port and Applier Product Code PT2XV…

Product: Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601, 03220609, 03220610, 06270601, 07170601, 09210601, 09270601, 20003156, ZHKBBB, ZJFBDK, ZJFBF6, ZJJBLR, ZJMBCD, ZJNBKW, ZKBBJV, ZKBBLK, ZKDB0B, ZKFBDG, ZKFBDJ, ZKGBBM, ZKGBDW, ZKHBCC, ZKHBDH, ZKKBDZ, ZKLBD9, ZKMBK1, ZKNBD7, ZLBBBJ, ZLCBC4, ZLCBGB, ZLDBBC, ZLFBGL, ZLGBC9 & ZLHBBJ.
Quantity: 2,520 pieces
Codes and lots: Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601, 03220609, 03220610, 06270601, 07170601, 09210601, 09270601, 20003156, ZHKBBB, ZJFBDK, ZJFBF6, ZJJBLR, ZJMBCD, ZJNBKW, ZKBBJV, ZKBBLK, ZKDB0B, ZKFBDG, ZKFBDJ, ZKGBBM, ZKGBDW, ZKHBCC, ZKHBDH, ZKKBDZ, ZKLBD9, ZKMBK1, ZKNBD7, ZLBBBJ, ZLCBC4, ZLCBGB, ZLDBBC, ZLFBGL, ZLGBC9 & ZLHBBJ.
Recall started: Sept. 27, 2010
Device type: Implant, Intragastric For Morbid Obesity
Root cause (FDA): Other
What the company told customers: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Recall number: Z-0304-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0289-2011, Z-0290-2011, Z-0291-2011, Z-0292-2011, Z-0293-2011, Z-0294-2011, Z-0295-2011, Z-0296-2011 and others. The agency record governs; check it and the company before acting.

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