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.
FDA Recall Z-1026-2010 · Posted 2010-03-08
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJTW
Date Initiated2009-10-12
Date Terminated2010-03-10
Product Quantity57150
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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