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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 25, 2005
Date Posted July 28, 2005
Recall Status1 Terminated 3 on December 02, 2005
Recall Number Z-1055-05
Recall Event ID 32165
510(K)Number K980987  
Product Classification Syringe, Piston - Product Code FMF
Product # 309604 -- Syringe 10 mL LL
Code Information 309604 Syringe 10 ML LL 5063484; 309604 Syringe 10 ML LL 5063495; 309604 Syringe 10 ML LL 5055564; 309604 Syringe 10 ML LL 5055567; 309604 Syringe 10 ML LL 5063493. 
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 firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
FDA Determined
Cause 2		 Other
Action BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
Quantity in Commerce 2028000 units
Distribution BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
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 BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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