Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisi
FDA device recall Z-0272-2009 · posted 2008-11-18 · Terminated
Recall details
- Recalling firm
- Theken Spine LLC
- Reason for recall
- The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010.
- Action taken
- On 8/27/2008 the firm sent recall notification letters to each of their customers notifying them of the problem with the product. They were requested to return any remaining product back to the recalling firm and to call Customer Service at (866) 942-8698 for an RGA and to arrange shipment. On 8/28/2008 the firm conducted follow up contact each distributor via telephone.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 115 total
- Distribution
- Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.
- Date initiated
- 2008-08-27
- Date posted
- 2008-11-18
- Date terminated
- 2012-04-13
- Location
- Akron, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANUAL BONE MARROW BIOPSY DEVICE (K993435) | Promex, Inc. | 1999-12-06 |