Class II

Medical Device Recall: Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

Medivance Inc. · February 16, 2024

Reason for Recall

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.

Distribution

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, Taiwan, Japan, China, Thailand.

States Affected

NATIONWIDE

Quantity Affected

1,654

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1381-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Medivance Inc. Medical Device Recall: Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C | SafeCheck