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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96092

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

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Event summary

Timeline bucket
January 02, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Belmont Instrument LLC

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

Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006

Z-1099-2025
Recall number
Z-1099-2025
Initiated
January 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Belmont Instrument LLC
Quantity
1,029 cases (12,348 sets)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

Code information

UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.