Filter, Infusion Line
General Hospital · 21 CFR 880.5440
Recent MDR events
1,167 adverse event reports on file
- MEDEX IV FILTER EXTENSION SETJul 7, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v1526863-2026-00137
- MICRO-VOLUME EXTENSION SETJun 24, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02122
- MICRO-VOLUME EXTENSION SETJun 24, 2026InjuryBaxter Healthcare Corporation1416980-2026-02123
- ICU MEDICAL 0.2 MICRON FILTERJun 17, 2026MalfunctionIcu Medical, IncMW5189603
- NON-DEHP MINIVOLUME EXTENSION SETJun 15, 2026MalfunctionBaxter Healthcare Corporation.25501015
- NAJun 5, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-01918
- INTERLINKJun 5, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-01924
- EXTENSION SETJun 5, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-01934
- EXTENSION SETMay 29, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-01828
- FLUID SYSTEMS ACCESSORIESMay 27, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-01770
Event type breakdown
Recalls
8 recall events for this product code
- Smiths Medical ASD Inc.TerminatedApr 21, 2021
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Z-1474-2021 · View FDA record ↗ - Pall Life Sciences Puerto Rico LlcTerminatedJun 30, 2011
Pall Total Nutrient Admixture Filter, 1.2 micron filter
Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures.
Z-2715-2011 · View FDA record ↗ - Millipore Corp.TerminatedJul 20, 2004
Millex-GS Syringe Filter Unit 0.22 um, Sterile
Lack of assurance of sterility
Z-0573-04 · View FDA record ↗ - Millipore Corp.TerminatedJul 20, 2004
Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile
Lack of assurance of sterility
Z-0574-04 · View FDA record ↗ - Millipore Corp.TerminatedJul 20, 2004
Millex-AA Syringe Driven Filter 0.8 um, Sterile
Lack of assurance of sterility
Z-0575-04 · View FDA record ↗ - Millipore Corp.TerminatedJul 20, 2004
Millex GS- Syringe Filter 0.22um, Sterile
Lack of assurance of sterility
Z-0576-04 · View FDA record ↗ - Millipore Corp.TerminatedJul 20, 2004
Millex HA Syringe Filter 0.45um, Sterile
Lack of assurance of sterility
Z-0577-04 · View FDA record ↗ - Halyard Health, IncTerminatedUnknown
CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr
The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window.
Z-1277-2018 · View FDA record ↗
Registered firms
96 firms currently registered for this product code
Pall International, Sarl
Fribourg, CH
Tech Group Grand Rapids, Inc.
GR, MI, US
Sterigenics Us, Llc
Lewis Center, OH, US
Millipore S.a.s
MOLSHEIM Grand Est, FR
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Steritech, Inc.
SALINAS, PR, US
Baxter Healthcare, S.a.
Haina San Cristobal, DO
Cbr Enterprise Limited
Hong Kong, HK
Merck Millipore Ltd.
COUNTY CORK Munster, IE
Saint Jones Management Lp Eood
Sofia Sofia-Grad, BG
Icu Medical Healthcare Manufacturing S.a. De C.v.
APODACA Nuevo Leon, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Hangzhou Qiantang Longyue Biotechnology Co.,ltd
Hangzhou Zhejiang, CN
Rg Medical Usa
Mount Juliet, TN, US
Cydonia Pharma Sl
valencia, ES
Sterigenics Us Llc
West Memphis, AR, US
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Vygon Usa
Lansdale, PA, US
Icu Medical, Inc.
SAN CLEMENTE, CA, US
510(k) clearances
98 clearances for this product code
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd.May 10, 2024
K233277 · Filter Needle for Single Use
- Merck Millipore , Ltd.Aug 11, 2015
K143583 · Cathivex ¿GV filter units
- Baxter Healthcare CorpDec 8, 2011
K113227 · NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
- Arteria Medical Science, Inc.Aug 22, 2002
K021293 · ARTERIA BLOOD FILTER
- Pall Corp.Dec 16, 1999
K993379 · PALL SUPOR AEF FILTER
- Sims Deltec, Inc.Feb 11, 1998
K974661 · 0.2 U BACTERIAL FILTER
- Arbor Technologies, Inc.Jan 22, 1997
K964283 · AUTOPRIME
- Pall Biomedical Products Co.Jan 9, 1997
K954331 · PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)