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U.S. Department of Health and Human Services

Class 2 Device Recall BD Integra

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  Class 2 Device Recall BD Integra see related information
Date Initiated by Firm January 27, 2007
Date Posting Updated March 03, 2007
Recall Status1 Terminated 3 on July 24, 2007
Recall Number Z-0582-2007
Recall Event ID 37248
510(K)Number k023752  
Product Classification Insulin Syringe - 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 NJ 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
Other
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 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) Database 510(K)s with Product Code = FMF and Original Applicant = BD
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