FDA Medical Device Recalls (openFDA)
Covidien LP: AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067
- Recall number
- Z-2657-2010
- Recalling firm
- Covidien LP
- Product
- AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067
- Status
- Terminated
- Initiated
- 2010-08-11
- Posted
- 2010-10-01
- Terminated
- 2012-06-12
- 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
- 1436 units (359 cases)
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 010/09, 011/09, 012/09, 013/09
- 510(k) numbers
- ["K951683"]
- PMA numbers
- not on file
- Product code
- JOW
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28