Recall Z-1074-2010 ยท FPA Set, Administration, Intravascular
Medical Action Industries Inc
Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
| Date | Mar 30, 2010 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI. |
| Quantity | 4,280 kits |
| 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 |