Recall Z-0550-2007 ยท FLD Apparatus, Hemoperfusion, Sorbent
Clark Research and Development Inc
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research and Development, Inc. Folsom, LA 70437
| Date | Feb 28, 2007 (initiated Jan 19, 2007) |
| Status | Terminated |
| Reason | Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions |
| Root cause | 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 | 15 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.