Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right
FDA device recall Z-2444-2015 · posted 2015-08-21 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- 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
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MPO
- Quantity affected
- 164, 749 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
- Date initiated
- 2015-07-31
- Date posted
- 2015-08-21
- Date terminated
- 2017-05-31
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RECOVER INFANT HEEL WARMER (5100) (K964523) | Florida Medical Industries, Inc. | 1997-02-10 |