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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton Dickinson and Company, Franklin Lakes, NJ 07417; Kit contains Sterile Screw-Cap collection cup with Integrated Transfer Device and 4.0 mL 13x75mm Plus Plastic C&S Preservative Tube and Castile Soap Towelettes.

Recall number
Z-1023-2010
Recalling firm
Becton Dickinson & Company
Product
BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton Dickinson and Company, Franklin Lakes, NJ 07417; Kit contains Sterile Screw-Cap collection cup with Integrated Transfer Device and 4.0 mL 13x75mm Plus Plastic 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
344950
Distribution
Nationwide distribution to hospitals and medical device distributors.
Lot, serial or model codes
Catalog number: 364954; lot number 9125230, Exp 11/2010; lot number 9148018, 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

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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

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