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Terminated

AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066

FDA Recall Z-2656-2010 · Posted 2010-10-01

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeJOW
Date Initiated2010-08-11
Date Terminated2012-06-12
Product Quantity1984 units (496 cases)

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

Firm 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.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951683A-V IMPULSE SYSTEM MODEL 6060Novamedix , Ltd. · 1995-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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