Recall Z-0753-2010 ยท FPA Set, Administration, Intravascular
Becton Dickinson Medical Systems
BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
| Date | Feb 2, 2010 (initiated Oct 19, 2009) |
| Status | Terminated |
| Reason | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. |
| Root cause | Process control |
| Action | 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= |
| Quantity | 37,900 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 Becton Dickinson Infusion Therapy Systems, Inc., Apr 16, 2002 |