Device Recall RX2 COUDE Epidural Needle

  • Model / Serial
    Lot No. 12168200; Ref No. 107-1416.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
  • Product Description
    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Epimed International, 13958 Diplomat Dr, Farmers Branch TX 75234-8805
  • Manufacturer Parent Company (2017)
  • Source
    USFDA