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.
Recall
- Recall Number
- Z-1026-2010
- Event Number
- 53650
- Firm
- Becton Dickinson & Company
- FEI Number
- 2243072
- Product Code
- JTW
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 12, 2009
- Posted
- March 8, 2010
- Terminated
- March 10, 2010
- Address
- 1 Becton Dr, Franklin Lakes, NJ, 07417-1815
Description
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.
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.
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.
Nationwide distribution to hospitals and medical device distributors.
57150