PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 3, 2024 Initiated: February 16, 2024 #Z-1381-2024

Product Description

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.

Details

Recalling Firm
Medivance Inc.
Units Affected
1,654
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.
Location
Louisville, CO

Frequently Asked Questions

What product was recalled?
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C. Recalled by Medivance Inc.. Units affected: 1,654.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1381-2024.