Z-2657-2010

AVI Sterile Impad Rigid Sole Foot Cover, Left Foot

Name: Z-2657-2010 AVI Sterile Impad Rigid Sole Foot Cover, Left Foot
Creator: Covidien LP
Published: 2010-08-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-08-11 / Terminated / root cause: sterility

FDA source

Covidien LP began a recall of AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067 on 2010-08-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2657-2010
Status: Terminated
Initiated: 2010-08-11
Posted: 2010-10-01
Terminated: 2012-06-12
Recalling firm: Medtronic, Inc.
Product: AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067
Product code: JOW Sleeve, Limb, Compressible
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
Root cause tag: sterility
FDA 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 in commerce: 1436 units (359 cases)
Distribution: Nationwide
Product codes and lots: Lot Numbers: 010/09, 011/09, 012/09, 013/09

Product code JOW

K951683Class IIA-V Impulse System Model 6060Novamedix , Ltd. / cleared 1995-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)