PlainRecordsFDA · Medical device recall
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture-… and 8 more products
- Date posted by the FDA
- July 17, 2007
- Status
- Terminated
- Filed by
- Teleflex Creek Dr
- Distribution pattern
- Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
9 products in this recall
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek…
- Product
- Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek, TOPS ASSY P/P SLING, Catalog #84414323
- Reason
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- Bondek¿, TOPS ASSY P/P SLING, Catalog #84414323, Lot #9591.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1011-2007
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek…
- Product
- Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
- Reason
- The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Lot numbers: 3244075; Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Lot #2361002; Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Lot #2401863 & 2498856; Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136, Lot #2443985 & 3080258; Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Lot #2528539, & 3163971; Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Lot #2554480.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1012-2007
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek…
- Product
- Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P,Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P,Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P
- Reason
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P, Lot #3328445; Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Lot #3313774 & 3200044; Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Lot #2297080 & 2467234; Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Lot #2486461; Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P, Lot #2351154; Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Lot #2351154; Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Lot #2306894 & 3308136; Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P, Lot #2324039; Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Lot #2262121 & 2306894; Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Lot #2306897; Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Lot #3211901& 3346174; Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Lot #2306899 & 2306900; Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Lot #3335219; Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P, Lot #3335220.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1013-2007
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures -Bondek…
- Product
- Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures -Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N, Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN, Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N, Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N
- Reason
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N, Lot #2535750; Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N, Lot #2297631; Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N, Lot #2396240, 2498757 & 2511511.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1014-2007
Various Types…
- Product
- Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6, SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399.
- Reason
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, Lot #105821; SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8, Lot #80513; SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, Lot #1015798; SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, Lot #67227; SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6 SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4, Lot #67228; SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, Lot #39238; SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, Lot #8727; SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399. Lot #72507.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1015-2007
Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR…
- Product
- Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
- Reason
- The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Lot #2503061, 2503063, 2761528, 2761529 2694983, 3152877, 3169994, 2395967, 3163970 & 3232258; Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Lot #2360982 & 2381287.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1016-2007
Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester…
- Product
- Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114
- Reason
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114, Lot #21486, 21487, 21488, 23468, 23469, 41910 & 55380.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1017-2007
Nonabsorbable Polypropylene Synthetic Suture-Deklene…
- Product
- Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123
- Reason
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123, Lot #35089.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1018-2007
Various Sizes of Sterile Polyglycolic Acid Synthetic Surgical Suture-NDR…
- Product
- Various Sizes of Sterile Polyglycolic Acid Synthetic Surgical Suture-NDR, POLYGLY 2-0 C-2/CST43 2N36, Catalog #833-135
- Reason
- Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Quantity
- 1920 units total for all types of sutures
- Codes and lots
- NDR, POLYGLY 2-0 C-2/CST43 2N36, Catalog #833-135, Lot #2721010.
- Recall started
- June 6, 2007
- Device type
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
- Recall number
- Z-1019-2007
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1011-2007, Z-1012-2007, Z-1013-2007, Z-1014-2007, Z-1015-2007, Z-1016-2007, Z-1017-2007, Z-1018-2007 and others. The agency record governs; check it and the company before acting.