Recall Z-1026-2010 ยท JTW System, Transport, Aerobic
Becton Dickinson & Company
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,
| Date | Mar 8, 2010 (initiated Oct 12, 2009) |
| Status | Terminated |
| Reason | 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 | Other |
| 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 Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174. |
| Quantity | 57150 |
| Distribution | Nationwide distribution to hospitals and medical device distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790366 | URINE CULTURE KIT Bd Becton Dickinson Vacutainer Systems Preanalytic, Apr 4, 1979 |