FDA recall Z-1381-2024

Medivance Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-02-16
Report date
2024-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2024