REPEATER H938099RGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412626635), received between Apr 16, 2025 and Apr 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Filling 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2025Filling Problem; Filling Problem

  IT WAS REPORTED THAT A REPEATER PUMP UNDER-DELIVERED SOLUTION. THE PUMP WAS USED TO PRODUCE SODIUM CHLORIDE BAGS. THE PUMP GAVE 50 ML LESS OUT OF THE 300 ML PER BAG. ONCE THE MEDICATION WAS ADDED TO THE SYRINGE, THE FINAL PREPARATION WAS CONCENTRATED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21852799 ↗