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U.S. Department of Health and Human Services

Class 3 Device Recall BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube

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  Class 3 Device Recall BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube see related information
Date Initiated by Firm February 14, 2013
Date Posted April 04, 2013
Recall Status1 Terminated 3 on August 06, 2013
Recall Number Z-1056-2013
Recall Event ID 64494
Product Classification Container, specimen, sterile - Product Code FMH
Product BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA,

The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

Code Information Catalog #3694991 appears as Catalog #364953 (Lot #1335484)
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
Manufacturer Reason
for Recall
The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible
FDA Determined
Cause 2
Employee error
Action BD Diagnostics sent a "Product Advisory Notice" dated February 14, 2013 via UPS Second Day Air to all end user customers. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product. For questions regarding this recall call 201-847-5033.
Quantity in Commerce 236,400 units
Distribution Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.
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.