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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/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan,
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
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