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U.S. Department of Health and Human Services

Class 3 Device Recall BD Vacutainer Urine Complete Kit

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  Class 3 Device Recall BD Vacutainer Urine Complete Kit see related information
Date Initiated by Firm October 12, 2009
Date Posted March 08, 2010
Recall Status1 Terminated 3 on March 10, 2010
Recall Number Z-1024-2010
Recall Event ID 53650
510(K)Number K024240  
Product Classification Culture media, non-propagating transport - Product Code JSM
Product BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens;
Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C.
Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS
Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes;
Becton Dickinson and Company, Franklin Lakes, NJ
Code Information Catalog number 364956; lot number: 9092972, Exp. 10/2010; Lot number 9125259, Exp. 11/2010.
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Richard Vales
Manufacturer Reason
for Recall
A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
FDA Determined
Cause 2
Action Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.
Quantity in Commerce 588900
Distribution Nationwide distribution to hospitals and medical device distributors.
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 = JSM and Original Applicant = BD