Home › BELMONT INSTRUMENT CORPORATION › CureWrap™ Pediatric 91-104cm, (single)
CureWrap™ Pediatric 91-104cm, (single)
BELMONT INSTRUMENT CORPORATION · Model 500-03536 · UDI-DI 07290012127342
DWJ
Prescription
1
510(k) clearances
26,819
Adverse events (54 deaths)
70
Recalls
92
Facilities
Description
Accessory for the CritiCool system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Gentherm Medical, LLC | Overheating of the 115V CPU board may cause the device to shut down. |
| 2026-07-13 | Gentherm Medical, LLC | Overheating of the 115V CPU board may cause the device to shut down. |
| 2026-07-13 | Gentherm Medical, LLC | Overheating of the 115V CPU board may cause the device to shut down. |
| 2025-05-13 | Belmont Instrument LLC | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconne |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
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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.