FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes; Becton Dickinson and Company, Franklin Lakes, NJ
- Recall number
- Z-1024-2010
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes; Becton Dickinson and Company, Franklin Lakes, NJ
- Status
- Terminated
- Initiated
- 2009-10-12
- Posted
- 2010-03-08
- Terminated
- 2010-03-10
- Reason
- 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
- 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 Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.
- Quantity
- 588900
- Distribution
- Nationwide distribution to hospitals and medical device distributors.
- Lot, serial or model codes
- Catalog number 364956; lot number: 9092972, Exp. 10/2010; Lot number 9125259, Exp. 11/2010.
- 510(k) numbers
- ["K024240"]
- PMA numbers
- not on file
- Product code
- JSM
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28