EasiSlush

Bridge To Life Ltd. · Model BTLE-1250 · UDI-DI 00860001991208

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.

Recalls

Date	Firm	Reason
2026-07-20	Paragonix Technologies Inc.	Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
2025-06-12	Bridge to Life Ltd	The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine
2022-03-21	Waters Medical Systems LLC	There is a potential for the WCM cassette pump head leaking solution.
2020-01-30	Organ Recovery Systems, Inc.	Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
2018-02-26	Preservation Solutions, Inc.	Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..
2010-09-24	Preservation Solutions Inc	Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.