Recall Z-0272-2009 ยท KNW Instrument, Biopsy
Theken Spine LLC
Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.
| Date | Nov 18, 2008 (initiated Aug 27, 2008) |
| Status | Terminated |
| Reason | The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010. |
| Root cause | Other |
| Action | 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. |
| Quantity | 115 total |
| Distribution | Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993435 | MANUAL BONE MARROW BIOPSY DEVICE Promex, Inc., Dec 6, 1999 |