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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 Recall
Becton Dickinson 1.0mL 28 G x 1/2" blister packaged insulin syringe
see related information
Date Posted November 07, 2011
Recall Status1 Open
Recall Number Z-0174-2012
Recall Event ID 60255
Premarket Notification
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, New Jersey 07417-1815
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Wafa Al-Rimawi
201-847-6795
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KZH and Original Applicant = BECTON DICKINSON & CO.
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