Device Recall Osmocoll COP Control Reference

  • 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
  • 1 Event

Manufacturer

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