Medivance Inc. Recall 94030
Description: Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Medivance Inc. Recall 94030 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1381-2024 |
| Event ID | 94030 |
| Event Description | Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C |
| Product Type | Devices |
| 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. |
| Quantity | 1,654 |
| Recall Reason | 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. |
| Device Classification | 20240403 |
| Device Code Info | REF/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 Date | 20240326 |
| Recall Initiation Date | 20240216 |
| Recalling Firm | Medivance Inc. |
| Initial Notification | Letter |
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