AVANOS 13549Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494135492), received between Mar 24, 2022 and Aug 9, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K052117); they may or may not involve this specific model.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2022Fluid/Blood Leak; Product Quality Problem

  PHARMACY TECHNICIAN USED A BAXTER REPEATER PUMP TO FILL A 100 ML/HOUR 100ML ECLIPSE HOMEPUMP. AFTER FINISHING THE DOSE, THE TECH NOTICED LIQUID ON THE HOOD SURFACE. UPON EXAMINATION OF THE ECLIPSE, THE TUBING WAS LEAKING WHERE IT CONNECTS TO THE INLINE FILTER. THREE OF THE SIX DOSES MADE WERE LEAKING FROM THE SAME SPOT. WE QUARANTINED THE LOT # (30170380) AND MADE ALL NEW DOSES USING A DIFFERENT LOT #. ON (B)(6) 2022, A PATIENT CALLED IN REPORTING THE SAME PROBLEM. HE HAD DISCARDED THE LEAKING DOSE. FDA SAFETY REPORT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198334 ↗
• MalfunctionMar 24, 2022Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 100 ML, FLOW RATE: 100 ML/HR, PROCEDURE: TREATMENT, CATHPLACE: MEDIPORT, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00019 FOR THE FIRST REPORT. IT WAS REPORTED THAT A 100 MILLILITER/HOUR (ML/HR) PUMP WAS USED FOR A 46 HOUR INFUSION, WHEN USUALLY A 2ML/HR PUMP IS USED. THE PATIENT RECEIVED 5FU (FLUOROURACIL) INFUSION OVER 2 HRS INSTEAD OF 46 HRS. THE PATIENT COMPLAINED OF INCREASED NAUSEA/VOMITING, HAND AND FOOT PEELING AND INCREASED FATIGUE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 03MAR2022 REPORTED THAT THERE WAS A 1 WEEK DELAY ON NEXT TREATMENT AND EXTRA ANTI-NAUSEA MEDS GIVEN AND THE PATIENT HAS RETURNED TO BASELINE.

  Patient problems: Fatigue; Nausea; Peeling; Vomiting

  MAUDE report 13874798 ↗
• InjuryMar 24, 2022Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 100 ML. FLOW RATE: 100 ML. PROCEDURE: 5FU, CANCER TREATMENT. CATHPLACE: MEDIPORT. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00020 FOR THE SECOND REPORT. IT WAS REPORTED THAT A 100 MILLILITER/HOUR (ML/HR) PUMP WAS USED FOR A 46HOUR INFUSION, WHEN USUALLY A 2ML/HR PUMP IS USED. THE PATIENT RECEIVED 5FU (FLUOROURACIL) INFUSION OVER 2HRS INSTEAD OF 46HRS. THE PATIENT COMPLAINED OF INCREASED NAUSEA/VOMITING, HAND AND FOOT PEELING AND INCREASED FATIGUE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 03MAR2022 REPORTED THAT THERE WAS A 1 WEEK DELAY ON NEXT TREATMENT AND EXTRA ANTI-NAUSEA MEDS GIVEN AND THE PATIENT HAS RETURNED TO BASELINE.

  Patient problems: Fatigue; Nausea; Peeling; Vomiting

  MAUDE report 13874580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052117. One submission often covers many models, so check the product and lot details in each record.

• Z-2111-2009 · Feb 11, 2008 · Terminated
  I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medicatio
• Z-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump
• Z-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump