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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson 30G1/2" Precision Glide" Needle

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 Class 2 Recall
Becton Dickinson 30G1/2" Precision Glide" Needle
see related information
Date Posted February 13, 2012
Recall Status1 Terminated on December 11, 2012
Recall Number Z-1009-2012
Recall Event ID 60988
Premarket Notification
510(K) Number
K021475 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications
Code Information Marketing Status: K021475 Device Listing Number: DQ41418 Reorder#300745, Lot#lll6090
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
For Additional Information Contact Mr. Greg Morgan
201-847-4344
Manufacturer Reason
for Recall
Becton Dickinson has identified clogged needles.
FDA Determined
Cause 2
DESIGN: Device Design
Action Becton Dickinson sent Urgent Product Recall letters dated October 18, 2011 and October 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to deterine if they have any of the affected product. If they have affected product customers should return the product to Beckton Dickinson. For any questions regarding this recall call 201-847-4344.
Quantity in Commerce 480,000 units
Distribution Nationwide Distribution including IL and NJ
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 = FMI and Original Applicant = BD
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