Z-1381-2024Class II

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

Name: Z-1381-2024 Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Creator: Medivance Inc.
Published: 2024-02-16
License: https://open.fda.gov/license/

Medivance Inc. / initiated 2024-02-16 / Open, Classified / root cause: manufacturing process

FDA source

Medivance Inc. began a recall of Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C on 2024-02-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1381-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-16
Posted: 2024-03-26
Recalling firm: Medivance Inc.
Product: Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Product code: DWJ System, Thermal Regulating
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/16/24, BD mailed or emailed recall notices to customers who were asked to do the following: 1) Immediately Discontinue Use 2) Immediately quarantine affected pads, record your inventory totals on the Customer Response Form, discard all devices within your facility's control per your facility's procedures. 3) Share this notice with any users of the product within your facilities or with any facility affected product was distributed to. 4) Complete and return the attached Customer Response Form to the BD contact noted on the form. If you require further assistance contact BD Customer Support at 1-844-823-5433. Say "Recall" when prompted M-F 8am -5pm CT.
Quantity in commerce: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1381-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1381-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26

Product code DWJ

K142702Class IIArctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadMedivance, Inc. / cleared 2014-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)