Events

Recall of Device Recall Osmocoll

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wescor, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46214
  • Event Risk Class
    Class 3
  • Event Number
    Z-1350-2008
  • Event Initiated Date
    2007-12-26
  • Event Date Posted
    2008-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67005
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    COP Calibrator/Osmolality Control - Product Code JJM
  • Reason
    Inaccurate readings; the control does not provide an accurate calibration value/readings when performing colloid osmotic pressure (cop) testing.
  • Action
    Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.

Device

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
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Wescor, Inc

Manufacturer

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