Device Recall Hospilak, Portex First Breath, MediChoice

  • Model / Serial
    Numerous lots produced between June 2009 and September 2010.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden and Switzerland, Israel, Jordan, Lebanon, Libya, Morocco, Saudi Arabia, United Arab Emirates, Russia, Australia, New Zealand, Japan and Vietnam.
  • Product Description
    Face Tent || Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. || Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Manufactured for Unomedical inc. || Hospilak Ref. No. 115-E, Face Tent, Adult 5 (1.5m) Tubing Manufactured for Unomedical inc. || Hospilak Ref. No. 116-E, Face Tent, Adult 6 (1.8 m) Aerosol Tubing Manufactured for Unomedical inc. || McKesson Aerosol Mask, Face Tent Adult, No Tubing Reorder No. 86-110E || Face Tent Adult, 6 (1.8m) Aerosol Tubing Reorder no. 86-116E || Smiths Medical Portex First Breath Adult Face Tent (Non-latex) Ref 001490 || Smiths Medical Portex First Breath Adult Face Tent with Tubing, 188cm (5 ft.) (Non-latex) Ref 001492 || Owens & Minor MediChoice Adult Face Tent Re-Order #RSP3000 and Face Tent, Adult 6 (1.8m) Aerosol Tubing Re-Order #RSP3060
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Convatec Inc., 200 Headquarters Park Drive, Skillman NJ 08558-2600
  • Manufacturer Parent Company (2017)
  • Source
    USFDA