Z-1676-2025Class II

Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set...

Name: Z-1676-2025 Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set...
Creator: Belmont Instrument LLC
Published: 2025-03-31
License: https://open.fda.gov/license/

Belmont Medical Technologies / initiated 2025-03-31 / Open, Classified / root cause: manufacturing process

FDA source

Belmont Instrument LLC began a recall of Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight... on 2025-03-31. FDA classified it as Class II and gives the reason as "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". 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-1676-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-31
Posted: 2025-04-25
Recalling firm: Belmont Medical Technologies
Product: 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).
Product code: LGZ Warmer, Thermal, Infusion Fluid
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Belmont Medical notified consignees on about 03/31/2025 via "URGENT MEDICAL DEVICE CORECTION" FedEx or emailed letter. Consignees were instructed to locate affected product and to return the customer Response Form indicating if any affected units were on hand. Consignees were also instructed to follow instructions provided in the letter to inspect affected lots and if any units are identified as having cracks or leaks during priming, they should be discarded. Lot number of the set should be noted and reported to Belmont Medical Technologies. Belmont has indicated that they will replace any product found defective or at the request of the user any affected product that has not been used.
Quantity in commerce: 136 sets
Distribution: 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.
Product codes and lots: Model Number: 902-00038. UDI-DI: 00896128002220. Lot Number: 20241013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1676-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1674-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-25
Z-1675-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-25
Z-1676-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-25

Product code LGZ

K152208Class IIThe Belmont Hyperthermia PumpBelmont Instrument Corporation / cleared 2015-09-02

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)