Recalls / —
—#139095
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
- FDA product code
- MPO — Infant Heel Warmer (Chemical Heat Pack)
- Device class
- Class 1
- Medical specialty
- Physical Medicine
- 510(k) numbers
- K964523
- Affected lot / code info
- Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X
Why it was recalled
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
Root cause (FDA determination)
Package design/selection
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Timeline
- Recall initiated
- 2015-07-31
- Posted by FDA
- 2015-08-21
- Terminated
- 2017-05-31
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #139095. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.