Medivance Inc. recalls Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

Recall date

February 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1381-2024

FDA classification

Class II

Brand / firm

Medivance Inc.

Sold / distributed

Worldwide - US Nationwide distribution including in the states of IL, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Australia, Singapore, South Korea, T…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C