Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center
FDA device recall Z-2134-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
- Action taken
- Consignees were notified by letter on/about 05/16/2008. They were instructed to stop distributing the affected lots immediately and destroy any of the product they may have. A Product Disposition form was attached to be completed and returned via fax to Greiner bio-one. Consignees instructed to notify their customers and to provide Greiner bio-one with a list of their customers that have received the item. If you have any questions contact Manfred Abel at 704-261-7823.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 1,606,005 units
- Distribution
- Class II Recall - Nationwide Distribution.
- Date initiated
- 2008-05-16
- Date posted
- 2008-09-11
- Date terminated
- 2009-08-21
- Location
- Monroe, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUETTE HOLDEX (K980768) | Greiner Meditech, Inc. | 1998-04-09 |