FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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.
- Recall number
- Z-1026-2010
- Recalling firm
- Becton Dickinson & Company
- 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.
- 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
- 57150
- Distribution
- Nationwide distribution to hospitals and medical device distributors.
- Lot, serial or model codes
- Catalog number 364988, lot number 9125270, Exp. 5/2011; lot number 9148024, Exp. 6/2011
- 510(k) numbers
- ["K790366"]
- PMA numbers
- not on file
- Product code
- JTW
- 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
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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