AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066
FDA device recall Z-2656-2010 · posted 2010-10-01 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- JOW
- Quantity affected
- 1984 units (496 cases)
- Distribution
- Nationwide
- Date initiated
- 2010-08-11
- Date posted
- 2010-10-01
- Date terminated
- 2012-06-12
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A-V IMPULSE SYSTEM MODEL 6060 (K951683) | Novamedix , Ltd. | 1995-10-26 |