VACUTAINER Brand Push Button Blood Collection Sets.
FDA device recall Z-0549-04 · posted 2004-02-25 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.
- Action taken
- BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded.
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 4400
- Distribution
- The firm was able to determine that the product was distributed to 3 customers: Long Beach Memorial, Long Beach, CA; Potomac Hospital, Woodbridge Prince William, VA; and St. Joseph Hospital, Orange, C
- Date initiated
- 2003-12-17
- Date posted
- 2004-02-25
- Date terminated
- 2004-03-15
- 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 |
|---|---|---|
| BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET (K011984) | Becton, Dickinson & CO | 2001-08-29 |