Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain

  • Model / Serial
    product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.
  • Product Description
    Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. || Medela Healthcare, || McHenry, IL 60051; || A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; || Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medela Inc, 1101 Corporate Dr, Mchenry IL 60050-7006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA