Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research a
FDA device recall Z-0550-2007 · posted 2007-02-28 · Terminated
Recall details
- Recalling firm
- Clark Research and Development Inc
- Reason for recall
- Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FLD
- Quantity affected
- 15
- Distribution
- Nationwide
- Date initiated
- 2007-01-19
- Date posted
- 2007-02-28
- Date terminated
- 2007-07-17
- Location
- Folsom, LA
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