Device Recall ciper

  • Model / Serial
    All Lot codes listed as follows are affected: 30K200116, 31A160060, 31A250027, 31B280077, 31E160051,31H030002, 31I140023, 31J050052,31J250065, 32C070041, 32I050037, 32K250019, 33A300046, 33C170028, 33E290076, 33H220008, 3L170057, 34B16D038, 34B26D062, 34E05D055, 34F09D079, 34H05D023, 34H25D034, 34T17D091,34J14D021, 34L16D040
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled device was distributed to a single direct account customer located in Alabama and to
  • Product Description
    MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medex Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Source
    USFDA