Apparatus, Hemoperfusion, Sorbent
Gastroenterology, Urology · 21 CFR 876.5870
Recent MDR events
50 adverse event reports on file
- MARS DISPOSABLENov 30, 2022MalfunctionBaxter Healthcare Corporation3007697864-2022-00002
- MARS DISPOSABLEApr 21, 2022InjuryBaxter Healthcare Corporation3007697864-2022-00001
- SERAPH 100Dec 30, 2021DeathExthera Medical CorporationMW5106397
- MARSDec 3, 2021MalfunctionBaxter Healthcare Corporation3007697864-2021-00002
- MARSNov 21, 2021MalfunctionBaxter Healthcare Corporation3007697864-2021-00001
- ADSORBA 150CJun 9, 2021MalfunctionBaxter Healthcare Corporation9611369-2021-00121
- SERAPH 100 MICROBIND AFFINITY BLOOD FILTERMay 18, 2021InjuryExthera Medical Corporation3014015528-2021-00001
- ADSORBA 300Feb 2, 2021MalfunctionBaxter Healthcare Corporation9611369-2021-00014
- MARSMay 19, 2020MalfunctionBaxter Healthcare Corporation3007697864-2020-00001
- MARSMar 17, 2020InjuryBaxter Healthcare Corporation3006552611-2020-00003
Event type breakdown
Recalls
7 recall events for this product code
- Gambro Renal Products, IncorporatedTerminatedAug 13, 2014
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Z-2206-2014 · View FDA record ↗ - Gambro Renal Products, IncorporatedTerminatedAug 13, 2014
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Z-2207-2014 · View FDA record ↗ - Clark Research and Development IncTerminatedFeb 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research and Development, Inc. Folsom, LA 70437
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Z-0550-2007 · View FDA record ↗ - Clark Research and Development IncTerminatedFeb 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 100mL, Clark Research and Development, Inc. Folsom, LA 70437
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Z-0551-2007 · View FDA record ↗ - Clark Research and Development IncTerminatedFeb 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 175 mL, Clark Research and Development, Inc. Folsom, LA 7043
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Z-0552-2007 · View FDA record ↗ - Clark Research and Development IncTerminatedFeb 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Z-0553-2007 · View FDA record ↗ - Baxter Healthcare CorporationTerminatedUnknown
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.
Z-0411-2018 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Gambro Dialysatoren Gmbh
HECHINGEN Baden-Wurttemberg, DE
Vantive Us Healthcare Llc
Deerfield, IL, US
Exthera Medical Corporation
Martinez, CA, US
Sterlab
SIGNES Var, FR
Steris Laboratories
Brooklyn Park, MN, US
Delcath Systems, Inc.
Queensbury, NY, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
Sterigenics U.s., Llc
Queensbury, NY, US
Delcath Systems, Inc.
Queensbury, NY, US
Cytosorbents, Inc.
Princeton, NJ, US
Isomedix Operations Inc.
CHESTER, NY, US
Vantive Healthcare Technologies Private Limited
Bangalore Karnataka, IN
510(k) clearances
11 clearances for this product code
- Gambro Renal Products, Inc.Mar 26, 2014
K133807 · MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
- Gambro Renal Products, Inc.Dec 14, 2012
K113313 · MOLECULAR ADSORBENT RECIRCULATING(MARS)
- Gambro Renal ProductsMay 27, 2005
K033262 · MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
- Hemocleanse, Inc.Sep 10, 1999
K992196 · BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
- Hemocleanse, Inc.Aug 13, 1999
K984546 · BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
- American Health Care Systems, Inc.Oct 22, 1997
K971015 · AHCS HEMOPERFUSION SYSTEM
- Hemocleanse, Inc.Feb 15, 1996
K953751 · BIOLOGIC-DT SYSTEM
- Asahi Medical Co., Ltd.Mar 17, 1989
K885017 · HEMOSORBA CH-500, CH-350 AND CH-180