Recall Z-0272-2009
Theken Spine LLC · initiated August 27, 2008
Product
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.
Codes / lots: Part Number is 50-20-001. Lot #: 100549 Overall kit Exp. Date: 02/2010, Syringe Exp. Date 10/2009, Marrow Loc Exp. Date: 02/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 02/2010; Lot #103016 Overall kit Exp. Date: 10/2010, Syringe Exp Date: 10/2009, Marrow Loc Exp. Date: 10/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 10/2010.
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0272-2009
- Initiated
- August 27, 2008
- Posted by FDA
- November 18, 2008
- Terminated
- April 13, 2012
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 115 total
- Distribution
- Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.
- Recalling firm
- Theken Spine LLC, Akron, OH