AVANOS 13561Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00193494135614), received between Sep 16, 2020 and Jun 9, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (19 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Improper Flow or Infusion

  THE CUSTOMER REPORTED A FAST FLOW CONDITION INVOLVING AN ELASTOMERIC INFUSION PUMP USED TO ADMINISTER FLUOROURACIL AS PART OF A FOLFOX PROTOCOL. THE INFUSION PUMP WAS INTENDED TO DELIVER THERAPY OVER 46 HOURS; HOWEVER, THE PATIENT RETURNED APPROXIMATELY THREE HOURS EARLIER THAN EXPECTED AND THE PUMP WAS ALREADY EMPTY. NO SIGNS OF DRUG EXTRAVASATION WERE REPORTED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25448994 ↗
• MalfunctionApr 25, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  START DATE: (B)(6). END DATE: (B)(6). IT WAS REPORTED "THE INFUSER WAS STARTED ON (B)(6), AN ENDED ON B)(6), THE DEVICE WAS SCHEDULED TO END AT 4 PM. THE PATIENT'S INFUSER RECEIVED 7-HOURS. THE DEVICE WAS SCHEDULED TO END ON (B)(6) 2023, BUT ENDED AT (B)(6)." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809951 ↗
• MalfunctionMar 10, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. START DATE: (B)(6) 2022 AT 7:30 PM. STOP DATE: (B)(6) 2023 AT 7:00 AM. IT WAS REPORTED THE "HOMEPUMP COMPLETED THE EXPECTED 46-HOURS INFUSION IN 35-HOURS, 30-MINUTES."THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16522603 ↗
• MalfunctionMar 1, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. START DATE: (B)(6) 2022 AT 15:00. IT WAS REPORTED THE ELASTOMERIC INFUSION PUMP ENDED 14 HOURS BEFORE THE SCHEDULED TIME. THE ELASTOMERIC INFUSER WAS INSTALLED AT 15:00 ON (B)(6) 2022 AND THE INFUSION ENDED AT 00:01 ON (B)(6) 2022. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16460500 ↗
• MalfunctionFeb 28, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN START DATE: (B)(6) 2022 AT 14:30 IT WAS REPORTED THE ELASTOMERIC INFUSION PUMP WAS FORECAST TO END THE INFUSION AT 14:30 PM ON 17-AUG; HOWEVER, THE INFUSION VOLUME COMPLETED 12-HOURS BEFORE THE SCHEDULED TIME AND END AT 00:01 ON 17-AUG-2022. THERE WAS NO REPORTED INJURY. THE PATIENT IS REPORTED TO BE "FOR THE TIME BEING IS DOING WELL BUT IS BEING MONITORED."

  Patient problems: Insufficient Information

  MAUDE report 16456773 ↗
• InjuryJan 19, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ADDITIONAL INFORMATION RECEIVED 18-JAN-2023 STATING THE PATIENT EXPERIENCED GENERAL MALAISE AND ABDOMINAL PAIN. THE PATIENT WAS TO RECEIVE "CLINICAL SUPPORT AND MEDICATIONS, IF NECESSARY, IN CASE OF CONTINUITY OF SYMPTOMS." THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Abdominal Pain; Insufficient Information; Malaise

  MAUDE report 16205128 ↗
• MalfunctionJan 19, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 2026095-2023-00008 FOR THE FIRST EVENT. REFER TO 2026095-2023-00009 FOR THE SECOND EVENT. REFER TO 2026095-2023-00011 FOR THE FOURTH EVENT. FILL VOLUME: 96 ML/HR. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN . CATHPLACE: UNKNOWN. START TIME (B)(6) 2022 AT 1400. END TIME (B)(6) 2022 AT 0200. IT WAS REPORTED THE PATIENT EXPERIENCED A RAPID INFUSION DURING USE. THE DEVICE INFUSED IN 36-HOURS INSTEAD OF 48-HOURS. THERE WAS NO REPORTED INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 16205127 ↗
• MalfunctionJan 19, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 2026095-2023-00009 FOR THE SECOND EVENT. REFER TO 2026095-2023-00010 FOR THE THIRD EVENT. REFER TO 2026095-2023-00011 FOR THE FOURTH EVENT. FILL VOLUME: 96 ML/HR, FLOW RATE: 2 ML/HR, PROCEDURE: UNKNOWN , CATHPLACE: CENTRAL, START TIME (B)(6) 2022 AT 1430,  END TIME (B)(6) 2022 AT  2200. IT WAS REPORTED THE PATIENT EXPERIENCED A RAPID INFUSION DURING USE. THE DEVICE INFUSED IN 31.5-HOURS INSTEAD OF 48-HOURS. THERE WAS NO REPORTED INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 16205122 ↗
• MalfunctionJan 19, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 2026095-2023-00008 FOR THE FIRST EVENT. REFER TO 2026095-2023-00010 FOR THE THIRD EVENT. REFER TO 2026095-2023-00011 FOR THE FOURTH EVENT. FILL VOLUME: 96 ML/HR. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: CENTRAL. START TIME: (B)(6) 2022 AT 1500.   END TIME: (B)(6) 2022 AT 0300.   IT WAS REPORTED THE PATIENT EXPERIENCED A RAPID INFUSION DURING USE. THE DEVICE INFUSED IN 36-HOURS INSTEAD OF 48-HOURS. THERE WAS NO REPORTED INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 16205120 ↗
• MalfunctionJan 5, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PUMP INFUSED OVER 35 HOURS INSTEAD OF THE INTENDED 44 HOURS. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16102497 ↗
• MalfunctionNov 9, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2022-00119 FOR THE FIRST EVENT. REFER TO 2026095-2022-00121 FOR THE THIRD EVENT. FILL VOLUME: 95 ML, FLOW RATE: UNKNOWN, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN. IT WAS REPORTED THERE WAS A REPORTED FAST FLOW EVENT. THE CLINICIANS WERE USING NOMINAL FILL VOLUMES FOR MEDICATION (CHEMOTHERAPY) TO INFUSE OVER 46-HOURS. THE INFUSION COMPLETED WAS COMPLETED TWO TO FIVE HOURS EARLY. THE USER NOTED ONCE THEY INCREASED THE DILUENT, THE ISSUE "CORRECTED ITSELF AND THEY HAVE NOT HAD ANY FURTHER INCIDENTS OF FAST FLOW. THERE WERE NO REPORTED SYMPTOMS OR INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 15764908 ↗
• MalfunctionNov 9, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2022-00120 FOR THE SECOND EVENT. REFER TO 2026095-2022-00121 FOR THE THIRD EVENT. FILL VOLUME: 100 ML. FLOW RATE: UNKNOWN. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. IT WAS REPORTED THERE WAS A REPORTED FAST FLOW EVENT. THE CLINICIANS WERE USING NOMINAL FILL VOLUMES FOR MEDICATION (CHEMOTHERAPY) TO INFUSE OVER 46-HOURS. THE PATIENT RETURNED TEN-TWELVE HOURS EARLIER THAN EXPECTED. THE USER NOTED ONCE THEY INCREASED THE DILUENT, THE ISSUE "CORRECTED ITSELF AND THEY HAVE NOT HAD ANY FURTHER INCIDENTS OF FAST FLOW. THERE WERE NO REPORTED SYMPTOMS OR INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 15764875 ↗
• MalfunctionNov 9, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2022-00119 FOR THE FIRST EVENT. REFER TO 2026095-2022-00120 FOR THE SECOND EVENT. FILL VOLUME: 95 ML, FLOW RATE: UNKNOWN, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN. IT WAS REPORTED THERE WAS A REPORTED FAST FLOW EVENT. THE CLINICIANS WERE USING NOMINAL FILL VOLUMES FOR MEDICATION (CHEMOTHERAPY) TO INFUSE OVER 46-HOURS. THE INFUSION COMPLETED WAS COMPLETED TWO TO FIVE HOURS EARLY. THE USER NOTED ONCE THEY INCREASED THE DILUENT, THE ISSUE "CORRECTED ITSELF AND THEY HAVE NOT HAD ANY FURTHER INCIDENTS OF FAST FLOW. THERE WERE NO REPORTED SYMPTOMS OR INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 15764639 ↗
• MalfunctionApr 11, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 95 ML, FLOW RATE: 2 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE/TIME INFUSION STARTED: (B)(6) 2022, 16:45. END DATE/TIME INFUSION: (B)(6) 2022, 07:00IT. IT WAS REPORTED, "WHEN THE PATIENT WENT TO THE CLINIC TO REMOVE THE PORTABLE INFUSER [ELASTOMERIC LFR PUMP], THE CAREGIVER REPORTED THAT AT 7 AM ON (B)(6) 2022, THE INFUSER WAS ALREADY EMPTY. THE INFUSER WAS PLACED ON (B)(6) 2022 AT 16:45HRS." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079826 ↗
• MalfunctionMar 25, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2022-00021 FOR THE FIRST REPORT. REFER TO 2026095-2022-00023 FOR THE THIRD REPORT. THE CLINICIAN REPORTED THAT THE PATIENT STATED THAT THE BALL EMPTIED FASTER THAN IT SHOULD HAVE. ADDITIONALLY, THE NURSE REVEALED THAT THE PATIENT WAS NOT TOLD THAT THE PUMP WAS TO REMAIN OUTSIDE OF BED COVERS AS SUCH ACTIVITY WOULD CAUSE INCREASED TEMPERATURE OF PUMP CONTENTS AND MAY CAUSE FAST FLOW. NO REPORTED INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901588 ↗
• MalfunctionMar 25, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2022-00022 FOR THE SECOND REPORT, REFER TO 2026095-2022-00023 FOR THE THIRD REPORT. THE CLINICIAN REPORTED THAT THE PATIENT STATED THAT THE BALL EMPTIED FASTER THAN IT SHOULD HAVE. ADDITIONALLY, THE NURSE REVEALED THAT THE PATIENT WAS NOT TOLD THAT THE PUMP WAS TO REMAIN OUTSIDE OF BED COVERS AS SUCH ACTIVITY WOULD CAUSE INCREASED TEMPERATURE OF PUMP CONTENTS AND MAY CAUSE FAST FLOW. NO REPORTED INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901586 ↗
• MalfunctionMar 25, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2022-00021 FOR THE FIRST REPORT. REFER TO 2026095-2022-00022 FOR THE SECOND REPORT. THE CLINICIAN REPORTED THAT THE PATIENT STATED THAT THE BALL EMPTIED FASTER THAN IT SHOULD HAVE. ADDITIONALLY, THE NURSE REVEALED THAT THE PATIENT WAS NOT TOLD THAT THE PUMP WAS TO REMAIN OUTSIDE OF BED COVERS AS SUCH ACTIVITY WOULD CAUSE INCREASED TEMPERATURE OF PUMP CONTENTS AND MAY CAUSE FAST FLOW. NO REPORTED INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901584 ↗
• MalfunctionFeb 4, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 241 ML, FLOW RATE: 5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT NOTED UPON "WAKING-UP" THE PUMP WAS EMPTY. THERE WAS NO TREATMENT REQUIRED. THE PATIENT IS DOING WELL AND IS BEING MONITORED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453241 ↗
• MalfunctionFeb 3, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT NOTED UPON "WAKING-UP" THE PUMP WAS EMPTY. THERE WAS NO TREATMENT REQUIRED. THE PATIENT IS DOING WELL AND IS BEING MONITORED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446411 ↗
• MalfunctionJul 7, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 93ML. FLOW RATE: UNKNOWN. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2021 14:44. INFUSION STOP TIME: (B)(6) 2021 0900. IT WAS REPORTED THAT THE PUMP DELIVERED MEDICATION THREE TIMES FASTER THAN INTENDED. HOSPITAL PERFORMED AN INJECTION OF NEULASTA FOR RECOVERY OF WHILE BLOOD CELL LEVELS IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED 17-JUN-2021 INDICATED THE INCIDENT WAS "RAPID INJECT OF ANTICANCER DRUG." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Low White Blood Cell Count

  MAUDE report 12131799 ↗
• MalfunctionMar 15, 2021Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2021-00044 FOR THE FIRST REPORT. FILL VOLUME: 95 ML. FLOW RATE: 2 ML/HR. PROCEDURE: CHEMOTHERAPY INFUSION. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP INFUSED TWO HOURS EARLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488197 ↗
• MalfunctionMar 15, 2021Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2021-00045 FOR THE SECOND REPORT .FILL VOLUME: 95 ML. FLOW RATE: 2 ML/HR. PROCEDURE: CHEMOTHERAPY INFUSION. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP INFUSED ONE DAY EARLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488192 ↗
• MalfunctionSep 16, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 100 ML. FLOW RATE: 2ML/HOUR. PROCEDURE: CHEMOTHERAPY/5FU. CATHPLACE: UNKNOWN. INFUSION START TIME: 1:30PM, (B)(6) 2020. INFUSION STOP TIME: (B)(6) 2020 "MIDDLE OF THE NIGHT". IT WAS REPORTED THAT THE PATIENT HAD A PUMP WITH 5FU (FLUOROURACIL) PLACED ON (B)(6) 2020 AT 1:30PM, WITH AN INTENDED PUMP COMPLETION/REMOVAL ON (B)(6) 2020 AT 11AM, FOR A TOTAL DELIVERY TIME OF 46 HOURS. THE CUSTOMER RETURNED TO THE OFFICE ON (B)(6) 2020 AT 9AM, REPORTING THAT THE PUMP HAD GONE EMPTY "IN THE MIDDLE OF THE NIGHT." THE PUMP WAS DESCRIBED AS "FLAT WHEN THE NURSES DC'D [DISPOSED OF IN HAZARDOUS MATERIALS WASTE] IT". THE CUSTOMER WAS DESCRIBED AS AN "EXPERIENCED USER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10543481 ↗

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