—#99380

Product

BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For use in aspiration of medications, typically in the pharmacy setting.

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Ref# 305213, Lot# 0007829

Why it was recalled

Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used.

Root cause (FDA determination)

Packaging

Action the firm took

BD sent an Urgent: Product Recall letter with return response forms to direct consignees on 03/01/11 and 03/02/11 via UPS. The letter identified the affected product and lot along with the reason for the recall. The letter asked customers to complete the enclosed Distributor Packing List and to follow the instructions provided on the Packing List for returning the affected product. The firm will issue a credit upon receipt of the affected product. Customers can contact BD Customer Service if they need assistance or have questions regarding the recall.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Worldwide Distribution -- USA, including the states of NJ, IL, LA, NM, OH, NV, and VA, and country of Canada.

Timeline

Recall initiated: 2011-03-01
Posted by FDA: 2011-05-13
Terminated: 2012-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99380. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.