FDA Device recall Z-1381-2024
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C by Medivance, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1381-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-16 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medivance |
| Distribution | US |
Product
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
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.
Identifiers
| code_info | REF/UDI-DI/Lot(Expiration Date): 31802/00801741132131/NGGX5390(31Oct2024), NGGX1179(31Oct2024), NGGX1156(31Oct2024),…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1381-2024%22
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