FDA-Device2024-04-03Class II
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Medivance Inc.
Hazard
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.
Sold states
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.
Affected count
1,654
Manufactured in
321 S Taylor Ave Unit 200, N/A, Louisville, CO, United States
Products
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2024Don't want to check this manually?
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