Infinity 1200 mL Feeding Bag Set with Enfit Connector INF1200-ERecalls & reported problems
Zevex International, Inc. · Infinity 1200 mL Feeding Bag Set with Enfit Connector · 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 10814844001959), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
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
Device problems
- Infusion or Flow Problem1
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.
MalfunctionApr 9, 2024Infusion or Flow Problem; Infusion or Flow Problem
THE INITIAL REPORTER STATED THAT THE INFINITY FEEDING BAGS WOULD OFTEN NOT PRIME AND WERE CAUSING PERSISTENT NO FLOW ALARMS. THEY STATED THAT THEY HAD THE PUMP REPLACED AND THE ISSUE CONTINUED, AND THAT THEY FOUND THE PUMP ALARMING NO FLOW AND THAT THE "MAJORITY OF THE FEEDING REMAINED IN THE BAG" AND THAT THIS CAUSED THE PATIENT TO MISS THAT FEEDING OVERNIGHT. THEY ALSO STATED THAT THEY'RE USING A FORMULA THAT IS BLENDERIZED AND THIS IS CAUTIONED AGAINST IN THE INFINITY MANUAL. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, THOSE ATTEMPTS WERE UNSUCCESSFUL. THEY HAD STATED THAT THERE WAS NO HARM CAUSED TO THE PATIENT BY THE DELAY. NO OTHER INFORMATION WAS PROVIDED. [COMPLAINT (B)(4)].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19071995 ↗
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- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
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- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
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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.
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