Device product
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
Z-0183-2018
Product summary
- Event
- Event 77415
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,839,340 units
- Official record key
device-enforcement:Z-0183-2018
Official wording
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.
Code information: Lot Numbers: 6291768, 6312558 & 6340590. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590.
Distribution pattern: Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA
Derived failure modes
-
Labeling or packaging
mislabel