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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94030

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 16, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medivance Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1381-2024
Recall number
Z-1381-2024
Initiated
February 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medivance Inc.
Quantity
1,654

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

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.