Recall Z-1937-2016 ยท FMF Syringe, Piston
Becton Dickinson & Company
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
| Date | Mar 25, 2016 |
| Status | Terminated |
| Reason | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices. |
| Root cause | Error in labeling |
| Action | Becton Dickinson sent via email and UPS Ground an "Urgent Voluntary Product Recall" Letter dated March 25, 2016 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notif |
| Quantity | 811,200 units |
| Distribution | Nationwide Distribution to NY only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110771 | BD SINGLE USE, HYPODERMIC SYRINGE Becton, Dickinson and Company, May 13, 2011 |