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FMS 281572Recalls & reported problems

Medos International Sàrl · FMS Fluid Management System 2.5mm FMS Outflow Cannula · Class 1

Quick summary

This Medos FMS outflow cannula has 103 adverse event reports, all of them about mismatched expiration dates printed on device labels. There were no deaths and no injuries. There are no recalls that name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
103
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10886705016310), received between Sep 9, 2020 and Feb 11, 2021 — classified as 103 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (103 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Markings/Labelling Problem103

Patient problems

  • No Consequences Or Impact To Patient60
  • No Clinical Signs, Symptoms or Conditions42
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314930 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OUTSIDE THE BOX OF 1572 2.5 MM FMS CANNULA PK/20 -SH DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314929 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5 MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314921 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN LEBANON THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314918 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN LEBANON THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314914 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OUTSIDE THE BOX OF 1572 2.5 MM FMS CANNULA PK/20 -SH DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314911 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314906 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN LEBANON THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314903 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN LEBANON THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314884 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314882 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314879 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314875 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6)THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314865 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314856 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314853 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314850 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314847 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314844 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314835 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314832 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022, WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314816 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED (B)(6) 2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED (B)(6) 2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314815 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022, WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314813 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314810 ↗
  • MalfunctionFeb 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED BY THE AFFILIATE IN LEBANON THAT THE EXPIRATION DATES ON THE LABEL OF EACH INDIVIDUALLY PACKAGED 1572 2.5MM FMS CANNULA DEVICE DID NOT MATCH. ACCORDING TO THE REPORT, THE EXPIRATION DATE AT THE TOP OF THE LABEL INDICATED 10/30/2022 WHILE THE EXPIRATION DATE ON THE BAR CODE AT THE BOTTOM OF THE LABEL SHOWED 10/30/2021. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11314809 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.