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U.S. Department of Health and Human Services

Class 2 Device Recall Clark Biocompatible Hemoperfusion

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  Class 2 Device Recall Clark Biocompatible Hemoperfusion see related information
Date Initiated by Firm January 19, 2007
Date Posting Updated February 28, 2007
Recall Status1 Terminated 3 on July 17, 2007
Recall Number Z-0553-2007
Recall Event ID 37289
Product Classification Hemoperfusion filter - Product Code FLD
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/
Clark Research and Development Inc
Number 13 Park Lane
Folsom LA 70437
For Additional Information Contact Mr. Jean Chandler
Manufacturer Reason
for Recall
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
FDA Determined
Cause 2
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
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.