Device Recall Oracle Oral Mask

  • Model / Serial
    Lot numbers for Part Numbers: 900HC451 (lot #s: 011001 to 011016), 900HC451T (lot #s: 011024 to 020517), HC451A (lot #s: 020523 to 040907), HC452A (lot #s: 031215 to 060503) & HC452F (lot #s: 040719 to 041102)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Fisher & Paykel Healthcare Inc, 15365 Barranca Parkway, Irvine CA 92618
  • Source
    USFDA