BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH
FDA device recall Z-0590-2008 · posted 2008-01-23 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
- Action taken
- BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 769,200 USA; 1,300 Canada
- Distribution
- Worldwide-USA and Canada
- Date initiated
- 2007-11-20
- Date posted
- 2008-01-23
- Date terminated
- 2008-09-08
- 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 |