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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 Device Recall Becton Dickinson 30G1/2" Precision Glide" Needlesee related information
Date Initiated by FirmOctober 08, 2011
Date PostedFebruary 13, 2012
Recall Status1 Terminated 3 on December 11, 2012
Recall NumberZ-1009-2012
Recall Event ID 60988
510(K)NumberK021475 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductBD 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 NJ 07417-1815
For Additional Information ContactMr. Greg Morgan
201-847-4344
Manufacturer Reason
for Recall		Becton Dickinson has identified clogged needles.
FDA Determined
Cause 2		Device Design
ActionBecton 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 Commerce480,000 units
DistributionNationwide Distribution including IL and NJ
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMI
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