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New Search Back To Search Results   Medical Device Recalls Class 3 Recall Osmocoll Date Recall Initiated December 26, 2007 Date Posted March 27, 2008 Recall Number Z-1350-2008 Product 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. 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. Recalling Firm/ Manufacturer Wescor, Inc 459 South Main Street Logan , Utah 84321-5207 For Addition Information Contact Wayne Barlow 435-752-6011 Ext. 1422 Reason For Recall 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. Quantity in Commerce 950 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.

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