Recalls / —
—#116319
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.
- FDA product code
- FMH — Container, Specimen, Sterile
- Device class
- Class 1
- Medical specialty
- Pathology
- Affected lot / code info
- Catalog #3694991 appears as Catalog #364953 (Lot #1335484)
Why it was recalled
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
Root cause (FDA determination)
Employee error
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2013-02-14
- Posted by FDA
- 2013-04-04
- Terminated
- 2013-08-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #116319. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.