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U.S. Department of Health and Human Services

Class 2 Device Recall BD 16 G x 1 in. Nokor" noncoring vented needle

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  Class 2 Device Recall BD 16 G x 1 in. Nokor" noncoring vented needle see related information
Date Initiated by Firm March 01, 2011
Date Posted May 13, 2011
Recall Status1 Terminated 3 on November 30, 2012
Recall Number Z-2192-2011
Recall Event ID 58451
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product BD Nokor Admix Needle
16 G x 1 TW (1.6mm x 25mm)
REF 305216 Sterile
BD, Franklin Lakes, NJ

For use in aspiration of medications, typically in the pharmacy setting.
Code Information Ref# 305213, Lot# 0007829
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan
Manufacturer Reason
for Recall
Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used.
FDA Determined
Cause 2
Action 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.
Quantity in Commerce 161,000 units
Distribution Worldwide Distribution -- USA, including the states of NJ, IL, LA, NM, OH, NV, and VA, and country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.