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U.S. Department of Health and Human Services

Class 3 Device Recall Osmocoll COP Control Reference

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  Class 3 Device Recall Osmocoll COP Control Reference see related information
Date Initiated by Firm December 26, 2007
Date Posted March 27, 2008
Recall Status1 Terminated 3 on March 27, 2008
Recall Number Z-1351-2008
Recall Event ID 46214
510(K)Number K834208  
Product Classification COP Control Reference - Product Code JJM
Product 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.
Code Information 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)
Recalling Firm/
Manufacturer		 Wescor, Inc
459 South Main Street
Logan UT 84321-5207
For Additional Information Contact Wayne Barlow
435-752-6011 Ext. 1422
Manufacturer Reason
for Recall		 Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.
Quantity in Commerce 75 vials
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJM and Original Applicant = WESCOR, INC.
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