Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.
FDA device recall Z-0447-03 · posted 2003-01-16 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.
- Action taken
- Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 141600
- Distribution
- The firm distributed this product nationwide to wholesalers and direct customers.
- Date initiated
- 2002-10-16
- Date posted
- 2003-01-16
- Date terminated
- 2004-04-15
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROTAINER BRAND TUBE WITH EDTA(K2) (K940905) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-08-02 |