Set, Perfusion, Kidney, Disposable
Gastroenterology, Urology · 21 CFR 876.5880
Recent MDR events
60 adverse event reports on file
- SERVATOR H HTK SOLUTIONMar 4, 2025InjuryGlobal Transplant Solutions3015942785-2025-70001
- CUSTODIOL HTK SOLUTIONJun 25, 2021InjuryEssential Pharmaceuticals/ Bretsch / Essential Pharmaceuticals, LlcMW5102155
- CUSTODIOLJun 24, 2021InjuryEssential Pharmaceuticals/ Bretsch / Dr. Franz Kohler Chemie GmbhMW5102126
- SERVATOR HMay 10, 2019InjuryS.a.l.f. Laboratorio FramacologicoMW5086577
- SPS-1Jun 30, 2017DeathOrgan Recovery Systems, Inc.96681021
- SPS-1Feb 3, 2017InjuryOrgan Recovery SystemsMW5067678
- SPS STATIC PRESERVATION SOLUTIONFeb 1, 2017MalfunctionOrgan Recovery Systems, Inc.6292203
- SPS-1Jan 30, 2017MalfunctionOrgan Recovery Systems, Inc.6285496
- SPS-1Jan 30, 2017MalfunctionOrgan Recovery Systems, Inc.6285497
- SPS-1Jan 30, 2017MalfunctionOrgan Recovery Systems, Inc.6285498
Event type breakdown
Recalls
4 recall events for this product code
- Dr Franz Koehler Chemie GmbhOpen, ClassifiedSep 26, 2024
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Potential for particles to be present in solution.
Z-3300-2024 · View FDA record ↗ - Baxter Healthcare Corp.TerminatedNov 8, 2016
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Potential presence of particulate matter on the blood side of the dialyzer
Z-0370-2017 · View FDA record ↗ - Teva Pharmaceuticals USA, Inc.TerminatedApr 18, 2012
ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags).
Lack of assurance of sterility
Z-1437-2012 · View FDA record ↗ - Organ Recovery Systems, Inc.TerminatedUnknown
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Organ preservation fluid recalled due to potential for bacterial contamination.
Z-1111-2017 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
S.a.l.f. Laboratorio Framacologico
Cenate Scotto Bergamo, IT
Institut Georges Lopez
Lissieu Auvergne-Rhone-Alpes, FR
Bridge To Life Ltd
Duluth, GA, US
Marizyme, Inc.
West Palm Bch, FL, US
August Bioservices, Llc
Nashville, TN, US
Us Specialty Formulations
Allentown, PA, US
Institut Georges Lopez
ST LAURENT DE CHAMOUSSET Rhone, FR
Organ Recovery Systems, Inc.
Itasca, IL, US
Dr. Franz Kohler Chemie Gmbh
BENSHEIM Hesse, DE
Fresenius Kabi Austria Gmbh
GRAZ Steiermark, AT
Lifecycle Biotechnologies, Llc
Cleburne, TX, US
Biocure Solutions, Llc Dba Biocure, Inc.
Peachtree Corners, GA, US
Biovire, Inc.
Brighton, MI, US
Waters Medical Systems, Llc
ROCHESTER, MN, US
510(k) clearances
19 clearances for this product code
- Bridge TO Life, Ltd.Jan 24, 2025
K241239 · OrganProtex HTK Solution
- Institut Georges LopezJun 14, 2022
K221386 · PERF-GEN Pulsatile Perfusion Solution
- Institut Georges LopezJun 14, 2022
K221387 · BEL-GEN Cold Storage Solution
- S.A.L.F. SpaDec 20, 2021
K211842 · Servator M SALF Solution
- Dr. Franz Kohler Chemie GmbHApr 24, 2020
K192408 · Custodiol HTK Solution
- S.A.L.F. SpaOct 20, 2017
K170150 · Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
- Waters Medical Systems, LLCAug 16, 2013
K121736 · PERF-GEN PULSATILE PERFUSION SOLUTION
- Waters Medical Systems, LLCJun 14, 2013
K121618 · BEL-GEN COLD STORAGE SOLUTION