Device Recall HiZel, trayless, wound dressing, sterile

  • Model / Serial
    There are no lot codes. The firm is recalling all trayless product from its shipment dated 3/28/2006.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    There are 47 customers which includes two large distributors/accounts and the rest are internet individual purchasers. These internet purchases amounts are 6 to 18 pieces at a time. There are no government accounts and no international accounts generating from EMBEEM.
  • Product Description
    HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Embeem Inc., 18 Ireland Brook Dr, N Brunswick NJ 08902-4761
  • Source
    USFDA