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U.S. Department of Health and Human Services

Class 2 Device Recall BD Integra

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 Class 2 Recall
BD Integra
see related information
Date Posted March 03, 2007
Recall Status1 Terminated on July 24, 2007
Recall Number Z-0582-2007
Recall Event ID 37248
Premarket Notification
510(K) Number
K023752 
Product Classification Syringe, Piston - Product Code FMF
Product BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2'' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin Lot 6073436
Code Information Lot # 6073436 Ref (Reorder number) 305282)
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
The needle becomes detached from the hub/syringe
FDA Determined
Cause 2
DESIGN: Process Design
Action Recall notification letters were sent via UPS second day air on January 27, 2007. Distributors were asked to provide end user contact information to recalling firm.
Quantity in Commerce 247,824 units
Distribution Nationwide
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 = FMF and Original Applicant = BD
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