FDA · Medical device recall

BD Q-Syte… and 18 more products

Feb. 2, 2010

Date posted by the FDA: Feb. 2, 2010
Status: Terminated
Filed by: Becton Dickinson Medical Systems
Reason: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Distribution pattern: Nationwide distribution.

19 products in this recall

BD Q-Syte…

Product: BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 950,000 units
Codes and lots: Lot Numbers 8268863, 8269020, 8275798, 8308321, 8308323, 8309553, 8331937, 8331940, 8354558, 9007921, 9009643, 9009646, 9028838, 9035029, 99035032.
Recall started: Oct. 19, 2009
Device type: Set, Administration, Intravascular
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0750-2010

BD Q-Syte Extension Set…

Product: BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 42,600 units
Codes and lots: Lot numbers: 8305510, 8331944.
Recall started: Oct. 19, 2009
Device type: Set, Administration, Intravascular
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0751-2010

BD Q-Syte Extension Set…

Product: BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 144,900 units
Codes and lots: Lot numbers: 8305511, 8308330, 8354561, 9012072
Recall started: Oct. 19, 2009
Device type: Set, Administration, Intravascular
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0752-2010

BD Q-Syte Vial Access Adapter…

Product: BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 37,900 units
Codes and lots: Lot numbers: 9007918, 9035042, 9035044.
Recall started: Oct. 19, 2009
Device type: Set, Administration, Intravascular
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0753-2010

MPS Acacia Extension Set…

Product: MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,
Quantity: 73,050 units
Codes and lots: Lot numbers: A1967, A1979, A2056.
Recall started: Oct. 19, 2009
Device type: Set, Administration, Intravascular
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0754-2010

MPS Acacia Extension Set…

Product: MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
Quantity: 45,350 units
Codes and lots: Lot numbers: A1950, A2399
Recall started: Oct. 19, 2009
Device type: Set, Administration, Intravascular
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0755-2010

MPS Acacia Tri-Extension Set…

Product: MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
Quantity: 2,300 units
Codes and lots: Lot number: A1951
Recall started: Oct. 19, 2009
Device type: Set, Administration, Intravascular
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0756-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383530, 24GA 0.56IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 28,000 units
Codes and lots: Lot numbers: 8238450, 8319936, 8345957, 9013868.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0829-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383531, 24GA 0.75IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 190,000 units
Codes and lots: Lot numbers: 8284049, 8284050, 8305438, 8308349, 8345951, 9013867, 9026722.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0830-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383532, 22GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 827,280 units
Codes and lots: Lot numbers: 8248349, 8259950, 8295761, 8296792, 8296793, 8309299, 8309662, 8311150, 8319961, 8322609, 8331771, 8338737, 8338738, 8358628, 9020033.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0831-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383533, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 47,200 units
Codes and lots: Lot numbers: 8291980, 8330279.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0832-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 8960 units
Codes and lots: Lot number: 8331763.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0833-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 1,021,600 units
Codes and lots: Lot number: 8248355, 8249034, 8249035, 8269338, 8270576, 8274565, 8275207, 8275210, 8283964, 8311167, 8312211, 8319016, 8347056, 9007360, 9015539, 9022039.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0834-2010

BD Nexiva HF Closed IV Catheter System…

Product: BD Nexiva HF Closed IV Catheter System, REF 383537, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 180,160 units
Codes and lots: Lot numbers: 8263294, 8270579, 8347058, 9013864.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0835-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383538, 20GA 1.75IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 5200 units
Codes and lots: Lot number: 8312220
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0836-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 303,280 units
Codes and lots: Lot number: 8263293, 8274555, 8275429, 8290311, 8340308, 9016819.
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0837-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 4960 units
Codes and lots: Lot number: 8340302
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0838-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383647, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 21,680 units
Codes and lots: Lot Number: 9034319
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0839-2010

BD Nexiva Closed IV Catheter System…

Product: BD Nexiva Closed IV Catheter System, REF 383649, 18GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.
Quantity: 13,360 units
Codes and lots: Lot Number: 9041552
Recall started: Oct. 19, 2009
Device type: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Root cause (FDA): Process control
What the company told customers: Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall number: Z-0840-2010

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0750-2010, Z-0751-2010, Z-0752-2010, Z-0753-2010, Z-0754-2010, Z-0755-2010, Z-0756-2010, Z-0829-2010 and others. The agency record governs; check it and the company before acting.

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