Device Recall Osmocoll

  • Model / Serial
    Lot Numbers: 6 units packages: 0256118, 0256131, 0256151, 0256195, 0256213, 0256248, 0256306, 0256354, 0257016, 0257113, 0257032, 0257071, 0257150, 100299, 100500, 100677, and 100183: Individual vials Lot Numbers: I-61-22 , expiration 4/08 and I-62-34, expiration 10/08; Only individual vials of SS-025 (Lot I-62-34, expiration 10/08 ) included in Osmocoll SS-039 of 6 unit package Lot Numbers: 0397032 and 100455.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Paraguay, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom.
  • Product Description
    Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Wescor, Inc, 459 South Main Street, Logan UT 84321-5207
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 100136, 100445, and 100558; Individual vials Lot Numbers: I-65-18, expiration 9/09 (low control) and I-65-19, expiration 7/09 (high control)
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide- USA, Argentina, Australia, Brazil, Canada, Denmark, England, France, Germany, Greece, Hungary, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Paraguay, Poland, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and The United Kingdom.
  • Product Description
    Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
  • Manufacturer