Device Recall ChoICE PT "J" Tip 182 cm guide Wire

  • Model / Serial
    Pouch codes are:Catalog No. 12160-01J, UPN H7491216001J1, batch 4536936, expiration date of 2004-01. The five pack box codes are: Catalog No. 12160-01J, UPN H7491216001J2, batch 4562262, expiration date 2004-01.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
  • Product Description
    Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assembies are packaged in a five-pack product box.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
  • Source
    USFDA