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U.S. Department of Health and Human Services

Class 3 Device Recall Osmocoll

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 Class 3 Device Recall Osmocollsee related information
Date Initiated by FirmDecember 26, 2007
Date PostedMarch 27, 2008
Recall Status1 Terminated 3 on March 27, 2008
Recall NumberZ-1350-2008
Recall Event ID 46214
510(K)NumberK834208 
Product Classification COP Calibrator/Osmolality Control - Product Code JJM
ProductOsmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.
Code Information 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.
FEI Number 1717966
Recalling Firm/
Manufacturer		 Wescor, Inc
459 South Main Street
Logan UT 84321-5207
For Additional Information ContactWayne 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
ActionConsignees were notified by Recall Notification letter on 01/11/2008, and asked to arrange for return of affected product.
Quantity in Commerce950 vials
DistributionWorldwide- 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 CycleTPLC 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) Database510(K)s with Product Code = JJM
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