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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Clark Biocompatible Hemoperfusion		see related information
Date Posted February 28, 2007
Recall Number Z-0553-2007
Product Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437
Code Information Lot numbers 564 though 577
Recalling Firm/
Manufacturer		 Clark Research and Development Inc
Number 13 Park Lane
Folsom, Louisiana 70437
For Additional Information Contact Mr. Jean Chandler
504-919-9311
Reason for
Recall		 Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Action The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.
Quantity in Commerce 276
Distribution Nationwide
 
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