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Infant Heel Warmer (Chemical Heat Pack)
FDA product code MPO · Class 1 · Physical Medicine
34
Registered devices
501
Adverse events
7
Recalls
11
510(k) clearances
Devices with this code
DeRoyal — DEROYAL INDUSTRIES, INC.Marketlab Inc — MARKETLAB INC.Infant Heel Warmer — INTERNATIONAL BIOMEDICAL, LTD.Sammons Preston — Performance Health Supply, LLCArgyle — Cardinal Health, Inc.AtlanticMED — Atlantic Trading LLCMEDLINE — MEDLINE INDUSTRIES, INC.Halyard — OWENS & MINOR DISTRIBUTION, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMEDLINE — MEDLINE INDUSTRIES, INC.ASP MEDICAL — Asp Global, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.Future Generation Medical — Global International L. L. C.CARDINAL HEALTH — Cardinal Health 200, LLCArgyle — Cardinal Health, Inc.HCS — DYAD MEDICAL SOURCING, LLCInfant Heel Snuggler — INTERNATIONAL BIOMEDICAL, LTD.GCB Medical Supply — GCB MEDICAL LLCWARMGEL INFANT HEEL WARMER — Coopersurgical, Inc.Medline — MEDLINE INDUSTRIES, INC.ASP MEDICAL — Asp Global, LLCNOVAPLUS — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-06-16 | Cardinal Health 200, LLC | Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer wi |
| 2021-11-29 | Philips North America Llc | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modifie |
| 2021-06-09 | Cardinal Health 200, LLC | A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resultin |
| 2021-06-09 | Cardinal Health 200, LLC | A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resultin |
| 2015-07-31 | Covidien LLC | Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations |
| 2015-07-31 | Covidien LLC | Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations |
| 2015-07-06 | CooperSurgical, Inc. | Product marketed without a 510(k) |
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