Recall Z-1797-2008 ยท FPK Tubing, Fluid Delivery
Mentor Texas, Inc
Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
| Date | Sep 5, 2008 (initiated Apr 21, 2008) |
| Status | Terminated |
| Reason | During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices. |
| Root cause | Other |
| Action | A Customer Letter was issued to all consignees by the firm on 4/21/2008. Consignees were informed that a recent testing of these products discovered a potential defect in the packaging configuration, which could result in a loss of package integrity. Consignees were asked to review inventory and dispose of product and contact firm for credit. |
| Quantity | 4,321 boxes. |
| Distribution | Class II Recall - Worldwide Distribution ---- including USA, Puerto Rico and countries of Argentina, Austria, Bermuda, Brazil, Canada, China, Costa Rica, Cyprus, Denmark, England, Germany, Greece, Guatemala, India, Italy, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Panama, Parag |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.