• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Clark Biocompatible Hemoperfusion

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Clark Biocompatible Hemoperfusion
see related information
Date Posted February 28, 2007
Recall Status1 Terminated on July 17, 2007
Recall Number Z-0551-2007
Recall Event ID 37289
Product Classification Apparatus, Hemoperfusion, Sorbent - Product Code FLD
Product Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 100mL, 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
Manufacturer Reason
for Recall
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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 1
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-