Recall Z-0183-2018 ยท FMF Syringe, Piston
Becton Dickinson & Company
BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
| Date | Nov 28, 2017 (initiated May 25, 2017) |
| Status | Terminated |
| Reason | Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle mL 12.7mm 30G. |
| Root cause | Labeling mix-ups |
| Action | BD sent recall notification letters to all direct consignees (wholesaler, hospital, and retail) on May 25, 2017. BD is requesting wholesalers (distributors) to notify any accounts or additional locations that may have received the recalled product from them. BD gives the option to distributors to provide their customer list to BD if they would like BD to notify their customers. BD is requesting retail pharmacies to notify consumers that may have received the recalled product from them. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590. A 2nd notification |
| Quantity | 7,839,340 units |
| Distribution | Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024112 | BD INSULIN SYRINGE Becton, Dickinson & CO, Jan 9, 2003 |