Device Recall DuraHook Neuro Elastic Retractors

  • Model / Serial
    Catalog numbers: 382800, Lot numbers: 01A1100009, 01A1100165, 01A1100251, 01A1100355, 01B1100028, 01B1100274, 01E1000297, 01F1000587, 01F1000588, 01F1000589, 01G1000138, 01G1000327, 01G1000433, 01G1000512, 01H1000112, 01H1000297, 01J1000548, 01K1000182, 01M1000218, 01M1000326 and 01M1000339.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Weck, DuraHook ¿ (6mm) and ¿ (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. || For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Manufacturer Parent Company (2017)
  • Source
    USFDA