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U.S. Department of Health and Human Services

Class 3 Device Recall BD 1 ml Integra TB Syringe

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 Class 3 Device Recall BD 1 ml Integra TB Syringesee related information
Date Initiated by FirmNovember 24, 2008
Date PostedJanuary 13, 2009
Recall Status1 Terminated 3 on March 27, 2009
Recall NumberZ-0619-2009
Recall Event ID 50235
510(K)NumberK023752 
Product Classification Syringe - Product Code MEG
ProductBD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.
Code Information Lot number 8078251
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactGreg Morgan
201-847-4344
Manufacturer Reason
for Recall		Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.
FDA Determined
Cause 2		Incorrect or no expiration date
ActionRecall letters were sent on November 24, 2008 to all direct customers and potential end users of the product by UPS second day air. BD requests that inventory be examined and affected product be quarantined and returned as per recall letter instructions. Questions should be directed to BD customer service at 888-237-2762, M-F 8.OO AM to 5:00 PM EST.
Quantity in Commerce334,400 units
DistributionGA, KS, OH, MO, FL, PA, KY and NY.
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 = MEG
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