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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile ImPad Rigid Sole Foot Cover

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  Class 2 Device Recall Sterile ImPad Rigid Sole Foot Cover see related information
Date Initiated by Firm August 11, 2010
Date Posted October 01, 2010
Recall Status1 Terminated 3 on June 12, 2012
Recall Number Z-2656-2010
Recall Event ID 56565
510(K)Number K951683  
Product Classification Sleeve, Limb, Compressible - Product Code JOW
Product AVI Sterile Impad Rigid Sole Foot Cover, Right Foot
Product Code:6066
Code Information Lot Numbers: 010/09, 011/09, 012/09 
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact
508-261-8000
Manufacturer 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
FDA Determined
Cause 2		 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 1984 units (496 cases)
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JOW and Original Applicant = NOVAMEDIX LTD.
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