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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 Covidiensee related information
Date Initiated by FirmJuly 31, 2015
Date PostedAugust 21, 2015
Recall Status1 Terminated 3 on May 31, 2017
Recall NumberZ-2444-2015
Recall Event ID 71784
510(K)NumberK964523 
Product Classification Infant heel warmer (chemical heat pack) - Product Code MPO
ProductCovidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
Code Information Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X
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
ActionMedtronic/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 Commerce164, 749 units
DistributionWorldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MPO
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