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 |
|
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.
|