FDA Recall
Terminated
Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.
Recall: Z-0447-03
·
Initiated October 16, 2002
Recall
- Recall Number
- Z-0447-03
- Event Number
- 25170
- Firm
- Becton Dickinson & Company
- FEI Number
- 2243072
- Product Code
- JKA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 16, 2002
- Posted
- January 16, 2003
- Terminated
- April 15, 2004
- Address
- 1 Becton Drive, Franklin Lakes, NJ, 07417
Description
Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.
Reason
Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.
Action
Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
Distribution
The firm distributed this product nationwide to wholesalers and direct customers.
Quantity
141600