Recall Z-0499-2020 ยท NGT Saline, Vascular Access Flush
Becton Dickinson & Company
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
| Date | Oct 14, 2019 |
| Status | Terminated |
| Reason | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. |
| Root cause | Packaging process control |
| Action | BD issued notifications to Customers via FedEx to Distributors, Pharmacies, and Consumers via Pharmacies on 10/14/19, advising of the problem, health risk and action to take: Immediately review your inventory for the specific Catalog and Lot number listed , discontinue use and destroy all product subject to the recall following your institutions process for destruction.2. Complete the Customer Recall Response Form. Questions or require further assistance, please contact 1-888-731-7973 between 8 AM and 5 PM ET Monday through Friday. |
| Quantity | 1,632,000 |
| Distribution | Distribution US Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe Becton, Dickinson and Company, Feb 2, 2017 |