FDA recall Z-0183-2018

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

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

Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA

Key facts

Status

Terminated

Initiation date

2017-05-25

Report date

2017-12-06

Termination date

2018-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2018