Aquastat 2T0805Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10859809005016), received between Oct 2, 2017 and Jul 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K111034); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJul 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CUSTOMER RETURNED ONE 5ML 0.9% SODIUM CHLORIDE FLUSH SYRINGE DUE TO IT HAVING ONE VISIBLE PARTICULATE INSIDE OF THE DEVICE. THE SYRINGE WAS NEVER USED AND WAS RETURNED. A PREVIOUS IDENTICAL EVENT OF THIS TYPE WAS REPORTED IN NOV OF 2024 AND THE PARTICULATE WAS SENT OUT FOR ANALYSIS. THE REPORT INDICATED IT APPEARED TO BE CONSISTENT WITH CORRUGATE FIBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22444771 ↗
• MalfunctionOct 2, 2017Product Quality Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  COMPLAINANT ENCOUNTERED A 0.9% SODIUM CHLORIDE FLUSH SYRINGE THAT APPEARED TO HAVE "RUST" IN THE SOLUTION. NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6909081 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111034. One submission often covers many models, so check the product and lot details in each record.

• Z-2394-2012 · Aug 15, 2012 · Terminated
  0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc.,
• Z-2393-2012 · Aug 15, 2012 · Terminated
  0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc.,