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.
FDA Recall Z-1023-2010 · Posted 2010-03-08
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJSM
Date Initiated2009-10-12
Date Terminated2010-03-10
Product Quantity344950
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide distribution to hospitals and medical device distributors.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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