Atlas FDA

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 aspira

FDA device recall Z-2192-2011 · posted 2011-05-13 · Terminated

Recall details

Recalling firm
Becton Dickinson & Company
Reason for recall
Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used.
Action taken
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.
Root cause
Packaging
Status
Terminated
Product code
FMI
Quantity affected
161,000 units
Distribution
Worldwide Distribution -- USA, including the states of NJ, IL, LA, NM, OH, NV, and VA, and country of Canada.
Date initiated
2011-03-01
Date posted
2011-05-13
Date terminated
2012-11-30
Location
Franklin Lakes, NJ

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