Skip to content
Recall Observatory FDA recall evidence

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

May 25, 2017

Class II

Product summary

Firm
Becton Dickinson & Company
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

    reason.labeling_packaging · v1.0.0

    mislabel