Z-1025-2010

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

Name: Z-1025-2010 BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens...
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 Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors... 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-1025-2010
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 Preservative Tube and C&S Preservative Tube for Midstream Specimens 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.
Product code: JSM Culture Media, Non-Propagating Transport
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: 226900
Distribution: Nationwide distribution to hospitals and medical device distributors.
Product codes and lots: Catalog # 364957, lot number 9125262, Exp. 11/2010

Product code JSM

K024240Class IBd Vacutainer Plus Plastic Urine C&s Preservayive Tubes and KitsBd / cleared 2003-03-26

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)