ClearanceBrief
Recall Z-1023-2010 ยท JSM Culture Media, Non-Propagating Transport

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.

DateMar 8, 2010 (initiated Oct 12, 2009)
StatusTerminated
ReasonA 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 causeOther
ActionRecall 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.
Quantity344950
DistributionNationwide distribution to hospitals and medical device distributors.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K024240BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
Bd, Mar 26, 2003