System And Accessories, Isolated Heart, Transport And Preservation
Gastroenterology, Urology · 21 CFR 876.5880
Recent MDR events
73 adverse event reports on file
- CELSIORJan 17, 2018InjuryInstitut Georges Lopez Sas0002123774-2017-00003
- CELSIORJan 17, 2018InjuryInstitut Georges Lopez Sas0002123774-2017-00002
- CUSTODIOL SOLUTIONMar 17, 2015InjuryMW5041573
- CELSIOR (CELSIOR ORGAN PRESERVATION SOLUTION)Dec 17, 2014InjuryGenzyme Polyclonals S.a.s.2950168-2014-70404
- CELSIORAug 27, 2014InjuryGenzyme Polyclonals S.a.s.2950168-2014-14770
- CELSIORAug 27, 2014DeathGenzyme Polyclonals S.a.s.2950168-2014-14767
- CELSIORAug 26, 2014InjuryGenzyme Polyclonals S.a.s.2950168-2014-14766
- CELSIORAug 25, 2014InjuryGenzyme Polycionals S. A. S.2950168-2014-54576
- CELSIORAug 25, 2014InjuryGenzyme Polyclonals S. A. S.2950168-2014-62235
- CELSIORAug 20, 2014InjuryGenzyme Polyclonals S.a.s.2950168-2014-12601
Event type breakdown
Recalls
2 recall events for this product code
- INSTITUT GEORGES LOPEZOpen, ClassifiedJul 30, 2025
Brand Name: Celsior Cold Storage Solution
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
Z-2220-2025 · View FDA record ↗ - Vitrolife, Inc.TerminatedJul 12, 2011
XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of d
Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.
Z-2795-2011 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
Fresenius Kabi Austria Gmbh
GRAZ Steiermark, AT
Waters Medical Systems, Llc
ROCHESTER, MN, US
S.a.l.f. Laboratorio Framacologico
Cenate Scotto Bergamo, IT
Dr. Franz Kohler Chemie Gmbh
BENSHEIM Hesse, DE
Transmedics, Inc.
Andover, MA, US
Paragonix Technologies, Inc.
Waltham, MA, US
Sanbor Medical Xiamen, Inc.
Xiamen Fujian, CN
Bridge To Life Ltd
Duluth, GA, US
Scientific Molding Corporation Ltd. Dba Smc Ltd.
Santa Rosa, CA, US
Carnamedica Sp Z O O
Warszawa Mazowieckie, PL
Sterigenics U.s., Llc
Schaumburg, IL, US
Institut Georges Lopez
Lissieu Auvergne-Rhone-Alpes, FR
Institut Georges Lopez
ST LAURENT DE CHAMOUSSET Rhone, FR
Isomedix Operations Inc.
Northborough, MA, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
510(k) clearances
13 clearances for this product code
- TransMedics, Inc.Nov 18, 2022
K222535 · OCS Lung Donor Flush Set
- TransMedics, Inc.Jul 29, 2021
K211314 · OCS Lung Solution
- S.A.L.F. SpaAug 14, 2019
K190063 · Servator C SALF Solution
- Paragonix TechnologiesOct 19, 2018
K182735 · Paragonix SherpaPak Cardiac Transport System
- Paragonix Technologies, Inc.Mar 30, 2018
K180194 · SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
- Paragonix Technologies, Inc.Nov 25, 2014
K143074 · Sherpa Pak Cardiac Transport System
- Paragonix Technologies, Inc.Feb 21, 2014
K133432 · SHERPA PAK CARDIAC TRANSPORT SYSTEM
- Paragonix Technologies, Inc.Feb 6, 2013
K123326 · SHERPA PAK CARDIAC TRANSPORT SYSTEM