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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson 1.0mL 28 G x 1/2" blister packaged insulin syringe

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  Class 2 Device Recall Becton Dickinson 1.0mL 28 G x 1/2" blister packaged insulin syringe see related information
Date Initiated by Firm June 15, 2011
Date Posted November 07, 2011
Recall Status1 Terminated 3 on July 27, 2015
Recall Number Z-0174-2012
Recall Event ID 60255
510(K)Number K024112  
Product Classification Introducer, syringe needle - Product Code KZH
Product 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920

Intended use: Subcutaneous injection of insulin.
Code Information K024112 D039612 Catalog Number 329424 Lot Number 0039920
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
201-847-5033
Manufacturer Reason
for Recall		 Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, BD, sent an "PRODUCT RECALL NOTIFICATION" letter and response form dated June 15, 2011 to their consignee/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately review their inventory for the affected product, remove the product from inventory, quarantine the product and return it to BD; if the product was further distributed, they should identify their customers and notify them at once, and complete and return the attached Tracking/Verification Form via fax to: 201-847-4853. If you have any questions, contact Customer Service at 1-800-237-2762, Monday -Thursday, 8:00am-6:30pm and on Friday, 8:00-5:30pm Eastern Standard Time.
Quantity in Commerce 10,230 shelf cartons (1,0230,000 syringes)
Distribution Nationwide Distribution.
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.
510(K) Database 510(K)s with Product Code = KZH and Original Applicant = BECTON DICKINSON & CO.
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