Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96617

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 31, 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

3 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 3

Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedure Pack (P/N 902-00048P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).

Z-1674-2025
Recall number
Z-1674-2025
Initiated
March 31, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Belmont Instrument LLC
Quantity
158 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

Code information

Model Number: 902-00045. UDI-DI: 00896128002589. Lot Numbers: 20241005, 20241108

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.

device · product 2 of 3

Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Outflow Patient Line (P/N 902-00039P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).

Z-1675-2025
Recall number
Z-1675-2025
Initiated
March 31, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Belmont Instrument LLC
Quantity
208 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

Code information

Model Number: 902-00037. UDI-DI: 00896128002213. Lot Numbers: 20241012, 20241107

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.

device · product 3 of 3

Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).

Z-1676-2025
Recall number
Z-1676-2025
Initiated
March 31, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Belmont Instrument LLC
Quantity
136 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

Code information

Model Number: 902-00038. UDI-DI: 00896128002220. Lot Number: 20241013

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.