Z-1026-2010

BD Vacutainer Urine Complete Kit with UA tube and C&C Preservative Tube for Midstream Specimens. C&S...

Name: Z-1026-2010 BD Vacutainer Urine Complete Kit with UA tube and C&C Preservative Tube for Midstream Specimens. C&S...
Creator: Becton Dickinson & Company
Published: 2009-10-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-10-12 / Terminated / root cause: sterility

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Urine Complete Kit with UA tube and C&C Preservative Tube for Midstream Specimens. C&S Preservative Boric Acid 6.70mg/ml, Sodium Formate 3.35... on 2009-10-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1026-2010
Status: Terminated
Initiated: 2009-10-12
Posted: 2010-03-08
Terminated: 2010-03-10
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Urine Complete Kit with UA tube and C&C Preservative Tube for Midstream Specimens. C&S Preservative Boric Acid 6.70mg/ml, Sodium Formate 3.35 mg/ml PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C., for In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ; Kit contains Sterile Screw-Cap Collection Cup and integrated Transfer Device and 10 mL, 16x100 mm Plus Plastic Round Bottom Tube with Preservative for urinalysis and 5.0 mL 16x75mm Glass C&S Preservative Tube and Castile Soap Towelettes.
Product code: JTW System, Transport, Aerobic
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.
Root cause tag: sterility
FDA root cause: Other
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 [email protected] or via telephone at 1-800-6310174.
Quantity in commerce: 57150
Distribution: Nationwide distribution to hospitals and medical device distributors.
Product codes and lots: Catalog number 364988, lot number 9125270, Exp. 5/2011; lot number 9148024, Exp. 6/2011

Product code JTW

K790366Class IUrine Culture KitBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1979-04-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)