NOVAPLUS V11450-040B (UDI 10192253061406)Recalls & reported problems

Cardinal Health 200, LLC · Novaplus Hot Pack Instant · Class 1

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10192253061406), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 12, 2024
REPORTED BY REGISTERED NURSE THAT AS HE SQUEEZED THE "NOVAPLUS HOT PACK INSTANT" TO ACTIVATE IT, THE CONTENTS SQUEEZED OUT THE TOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095969 ↗

Device details

UDI-DI	`10192253061406`
Brand	NOVAPLUS
Model	V11450-040B
Company	Cardinal Health 200, LLC
Product code	IMD · PACK, HOT OR COLD, DISPOSABLE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 12, 2026

Device type (GMDN): Musculoskeletal hot/cold therapy pack, single-use

A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device.

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All PACK, HOT OR COLD, DISPOSABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.