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DeRoyal
DEROYAL INDUSTRIES, INC. · Model HNICU-100 · UDI-DI 00749756312929
MPO
Prescription
10
510(k) clearances
466
Adverse events
7
Recalls
23
Facilities
Description
Infant Heel Warmer
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 with tape. |
| 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 modified labeling cannot be |
| 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 resulting in the contents sp |
| 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 resulting in the contents sp |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.