Date Initiated by Firm |
January 19, 2007 |
Date Posted |
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
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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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