Recall Z-0183-2018— Becton Dickinson & Company

Name: FDA recall Z-0183-2018
Creator: U.S. Food and Drug Administration
Published: 2017-05-25

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2017-05-25, terminated 2018-06-27. It names one FDA 510(k) clearance: K024112. 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: 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..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Terminated: 2018-06-27
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K024112 — BD INSULIN SYRINGEBecton, Dickinson & CO·cleared 2003-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.