Device Recall Bone Marrow Aspiration Kit

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Theken Spine LLC, 1800 Triplett Blvd, Akron OH 44306-3311
  • Manufacturer Parent Company (2017)
  • Source
    USFDA