Recall Z-2673-2014 ยท NGT Saline, Vascular Access Flush
Becton Dickinson & Company
BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.
| Date | Sep 22, 2014 (initiated Jul 22, 2014) |
| Status | Terminated |
| Reason | BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553). |
| Root cause | Packaging |
| Action | BD sent recall letters/recall response cards dated 7/22/2014 via e-mail or UPS 2nd day mail. Customers are asked to examine their inventory and quarantine any affected product subject to recall. Customers should complete the Recall Response Card and fax it back to BD at 1-201-847-6990. Any questions can be directed to 1-888-237-2762 option 3. |
| Quantity | 3,088,320 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121050 | 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE Becton, Dickinson & CO, Feb 7, 2013 |