—#86265

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.

FDA product code: JSM — Culture Media, Non-Propagating Transport
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K024240
Affected lot / code info: Catalog number: 364954; lot number 9125230, Exp 11/2010; lot number 9148018, Exp. 11/2010.

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 #86265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.