Home › INSTITUT GEORGES LOPEZ › PERF-GEN Pulsatile Perfusion Solution

PERF-GEN Pulsatile Perfusion Solution

INSTITUT GEORGES LOPEZ · Model PERF-GEN/1000/US · UDI-DI 13700911900492

KDL Prescription

510(k) clearances

Adverse events (3 deaths)

Recalls

Facilities

Description

Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Recalls

Date	Firm	Reason
2024-01-09	Dr Franz Koehler Chemie Gmbh	Potential for particles to be present in solution.
2016-12-14	Organ Recovery Systems, Inc.	Organ preservation fluid recalled due to potential for bacterial contamination.
2016-10-12	Baxter Healthcare Corp.	Potential presence of particulate matter on the blood side of the dialyzer
2012-03-30	Teva Pharmaceuticals USA, Inc.	Lack of assurance of sterility

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.