Recall Z-1675-2025— Belmont Instrument LLC

Name: FDA recall Z-1675-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-31

Class II · Ongoing

Class II FDA medical device recall by Belmont Instrument LLC, initiated 2025-03-31. It names one FDA 510(k) clearance: K152208. Product: 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).. Reason: 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..

Recalling firm: Belmont Instrument LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-31
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K152208 — The Belmont Hyperthermia PumpBelmont Instrument Corporation·cleared 2015-09-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.