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Class 3 Device Recall BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube |
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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
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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.
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Code Information |
Catalog #3694991 appears as Catalog #364953 (Lot #1335484) |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact |
Ms. Yogindra Dellow 201-847-5033
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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
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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
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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.
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