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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm July 31, 2015
Date Posted August 21, 2015
Recall Status1 Terminated 3 on May 31, 2017
Recall Number Z-2443-2015
Recall Event ID 71784
510(K)Number K964523  
Product Classification Infant heel warmer (chemical heat pack) - Product Code MPO
Product Covidien Argyle Infant Heel Warmers (no tab)
Item Code: MH00002N

Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
Code Information Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
203-492-5000
Manufacturer Reason
for Recall		 Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
FDA Determined
Cause 2		 Package design/selection
Action Medtronic/Covidien issued an Urgent Medical Device recall letter dated July 31, 2015 via mailed Certified. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to quarantine and discontinue use of the affected products.. For questions or concerns,contact Medtronic representative or Customer Service at (800)-882-5878.
Quantity in Commerce 68,800 units
Distribution Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
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 = MPO and Original Applicant = FLORIDA MEDICAL INDUSTRIES, INC.
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