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Medivance Inc. Recall 94030

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

Medivance Inc. Recall 94030 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1381-2024
Event ID94030
Event DescriptionMedivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Product TypeDevices
DistributionWorldwide - 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.
Recall ReasonNeonatal 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.
Device Classification20240403
Device Code InfoREF/UDI-DI/Lot(Expiration Date): 31802/00801741132131/NGGX5390(31Oct2024), NGGX1179(31Oct2024), NGGX1156(31Oct2024), NGHP2415(28Feb2025), NGHP2411(28Feb2025), NGHT1139(31May2025), NGHTY603(31May2025), NGHV4383(31Jul2025), NGHW1507(31Aug2025); 3180202/10801741132138/NGGZ2622(31Dec2024), NGGV1829(31Aug2024), NGGW3254(30Sep2024), NGHQ2940(31Mar2025); 31802C/00801741223457/NGGV1784(31Aug2024)
Center Classification Date20240326
Recall Initiation Date20240216
Recalling FirmMedivance Inc.
Initial Notification Letter
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