—#86268

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.

FDA product code: JTW — System, Transport, Aerobic
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K790366
Affected lot / code info: Catalog number 364988, lot number 9125270, Exp. 5/2011; lot number 9148024, Exp. 6/2011

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide distribution to hospitals and medical device distributors.

Timeline

Recall initiated: 2009-10-12
Posted by FDA: 2010-03-08
Terminated: 2010-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86268. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.