AVANOS 13551Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494135515), received between Jul 13, 2021 and Sep 15, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Excess Flow or Over-Infusion

  It was reported that the pump had less volume than expected. Patient injury and medical intervention information were not provided.

  Patient problems: Insufficient Information

  MAUDE report 50771247 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 103ML. FLOW RATE: 200ML/HR. PROCEDURE: UNKNOWN. CATHETER PLACEMENT: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED VIA MW5101625 THAT "PATIENT HAD RASH, NAUSEA, AND FACIAL DYSESTHESIA." PER ADDITIONAL INFORMATION RECEIVED 9 JUL 2021, "PATIENT IS A (B)(6) YEAR OLD (B)(6) KG MALE TREATED WITH CEFTRIAXONE. PATIENT IS STABLE. THE ECLIPSE SIZE USED WAS 200 ML/HR 100 ML. DEVICE WAS FILLED WITH 83 ML OF SODIUM CHLORIDE 0.9% SOLUTION, PRIMED, THEN 20 ML OF CEFTRIAXONE WAS ADDED TO THE DEVICE. THE DEVICE WAS DISCARDED BY THE PATIENT CAREGIVER." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Nausea; Peripheral Nervous Injury; Rash

  MAUDE report 12162456 ↗

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-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump
• Z-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump