Recall Z-1121-2019 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
| Date | Mar 5, 2019 |
| Status | Terminated |
| Reason | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product. |
| Root cause | Under Investigation by firm |
| Action | On March 5, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that product was being recalled due to reports of kinked tubing which can lead to occlusion of the sets and reduction in the rate of infusion. Please Take the Following Actions: 1. Immediately review your inventory for the specific Catalogues (Ref) and lot numbers listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that t |
| Quantity | 21220 total cases of 20 |
| Distribution | Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931173 | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH Imed Corp., Apr 15, 1994 |