Z-0183-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2017
- Initiation Date
- May 25, 2017
- Termination Date
- June 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,839,340 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA
Code Information
Lot Numbers: 6291768, 6312558 & 6340590. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590.