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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 Recall
BD 1 ml Integra TB Syringe
see related information
Date Posted January 13, 2009
Recall Status1 Terminated on March 27, 2009
Recall Number Z-0619-2009
Recall Event ID 50235
Premarket Notification
510(K) Number
K023752 
Product Classification Syringe, Antistick - Product Code MEG
Product BD 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
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
For Additional Information Contact Greg 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
EXPIRATION DATING: Incorrect or No Expiration Date
Action Recall 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 Commerce 334,400 units
Distribution GA, KS, OH, MO, FL, PA, KY and NY.
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 = MEG and Original Applicant = BD
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