Filter, Infusion Line
FDA adverse event reports and recall history for filter, infusion line (product code FPB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,166
- Deaths
- 3
- Injuries
- 89
- Malfunctions
- 1,038
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2021-04-21TerminatedProcess control
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.
- 2011-06-30TerminatedLabeling mix-ups
Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.
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.
- 2004-07-20TerminatedOther
Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS
Lack of assurance of sterility
- 2004-07-20TerminatedOther
Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile Catalog Number: SLHAM33SS
Lack of assurance of sterility
- 2004-07-20TerminatedOther
Millex-AA Syringe Driven Filter 0.8 um, Sterile Catalog Number: SLAAM33SS
Lack of assurance of sterility
- 2004-07-20TerminatedOther
Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS
Lack of assurance of sterility
- 2004-07-20TerminatedOther
Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS
Lack of assurance of sterility
- TerminatedUnder Investigation by firm
CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
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.
Monitor filter, infusion line automatically
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