Medical device recalls Moderate risk

BD Insulin Syringes with the BD Ultra-Fine needle ¿ mL 12 recalled over labeling errors

Recall date
May 25, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Becton Dickinson & Company recalls BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are inten…
Recall number
Z-0183-2018
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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