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Medivance Inc.

Medivance Inc. Recalls

All product recalls associated with Medivance Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Jun 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–3 of 3 recalls

Arctic Sun Temperature System (Medivance) – Temperature Control Issue (2024)

If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

FDAJun 27, 2024Nationwide• Medivance Inc.

Medivance Inc.: Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 3...

Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

FDAFeb 16, 2024Nationwide• Medivance Inc.

MEDIVANCE INC.: Arctic Sun Temperature Management System

Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

FDAJan 5, 2005AL, AZ, CO +18 more• MEDIVANCE INC.