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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-0552-2007
Recall Event ID 37289
Product Classification Hemoperfusion filter - Product Code FLD
Product Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 175 mL, Clark Research and Development, Inc. Folsom, LA 70437
Code Information Lot numbers 564 through 577
Recalling Firm/
Manufacturer
Clark Research and Development Inc
Number 13 Park Lane
Folsom LA 70437
For Additional Information Contact Mr. Jean Chandler
504-919-9311
Manufacturer Reason
for Recall
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
FDA Determined
Cause 2
Other
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 unknown
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.
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