Fenwal Blood Comp. Recipient Set with Std. Blood Filter with Luer Adapter 4C2160Recalls & reported problems
Fresenius Kabi AG · Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Sterile Fluid Path · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052682004148), received between Sep 30, 2024 and Sep 30, 2024 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2024
REGISTERED NURSE (RN) WAS PREPARING TO GIVE A BLOOD TRANSFUSION TO A NEONATE PATIENT. SHE BEGAN BY PRIMING THE TUBING, BUT AS SHE DID, THE TUBING IMMEDIATELY BEGAN TO LEAK. IT WAS LEAKING AT THE FILTER. THE PATIENT WAS NEVER HOOKED UP TO THE TUBING, THUS I DID NOT INCLUDE PATIENT INFORMATION IN THIS REPORT. THE RN GOT NEW TUBING, COMPLETED PRIMING, AND THEN THE PATIENT GOT THE TRANSFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20332594 ↗
Other Set, Blood Transfusion devices
- CLEARLINK 2C8750Baxter Healthcare Corporation · Set, blood transfusion176 reports
- Blood Administration Set V2500B. Braun Medical Inc. · Set, blood transfusion1 recall2 reports
- CLEARLINK 4C8723Baxter Healthcare Corporation · Set, blood transfusion1 death30 reports
- INTERLINK 2C6750HBaxter Healthcare Corporation · Set, blood transfusion18 reports
- INTERLINK 2C6700Baxter Healthcare Corporation · Set, blood transfusion8 reports
- Blood Administration Set V2400B. Braun Medical Inc. · Set, blood transfusion7 reports
- Baxter 2C7627Baxter International Inc. · Set, blood transfusion7 reports
- CLEARLINK 2C8720Baxter Healthcare Corporation · Set, blood transfusion5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page