Recall Z-2656-2010 ยท JOW Sleeve, Limb, Compressible
Covidien LP
AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066
| Date | Oct 1, 2010 (initiated Aug 11, 2010) |
| Status | Terminated |
| Reason | Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any questions please contact, Covidien Customer Service at (800) 962-9888, Option 1. |
| Quantity | 1984 units (496 cases) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951683 | A-V IMPULSE SYSTEM MODEL 6060 Novamedix , Ltd., Oct 26, 1995 |