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.
FDA Recall Z-0272-2009 · Posted 2008-11-18
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Recalling FirmTheken Spine LLC
Recall StatusTerminated
Product CodeKNW
Date Initiated2008-08-27
Date Terminated2012-04-13
Product Quantity115 total
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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