Medivance Neonatal ArcticGel Pads Recalled for Reduced Water Flow
Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device (neonatal temperature management) with a functional defect that could affect patient care. However, no injuries or illnesses have been reported. Per FDA rubric, risk-of-harm products without reported injury score at most 3 (High). The Class II classification confirms this is a serious but non-critical defect.
Plain-English summary
Medivance Inc. is recalling 1,654 units of Neonatal ArcticGel Pads (REF: 31802, 3180202, 31802C) because the pads may experience reduced water flow. This malfunction can reduce or prevent water heating or cooling performance in the temperature management system.
Affected units have been distributed worldwide, including throughout the United States (50 states, Washington DC, and Puerto Rico) and internationally to Belgium, Australia, Singapore, South Korea, Taiwan, Japan, China, and Thailand. Specific lot numbers and expiration dates are provided by the manufacturer.
If you use these pads in a neonatal care setting, verify your lot numbers against the recall list. Contact Medivance Inc. for instructions regarding affected units. Do not use pads that are suspected of having reduced water flow or inadequate heating/cooling performance.
The recalled product
- Product
- Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
- Manufacturer
- Medivance Inc.
- Affected units
- 1,654
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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)
Distribution
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