Z-1056-2013Class III

BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953...

Name: Z-1056-2013 BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953...
Creator: Becton Dickinson & Company
Published: 2013-02-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-02-14 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of 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... on 2013-02-14. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1056-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-14
Posted: 2013-04-04
Terminated: 2013-08-06
Recalling firm: Becton Dickinson & Co
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.
Product code: FMH Container, Specimen, Sterile
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
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Catalog #3694991 appears as Catalog #364953 (Lot #1335484)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1056-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1056-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-04

Product code FMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)