Aquastat 2T0806Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10859809005023), received between Jun 24, 2022 and Dec 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. 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.

• MalfunctionDec 10, 2024Contamination; Contamination

  DISTRIBUTOR RETURNED ONE UNUSED 10ML 09% SODUIUM CHLORIDE FLUSH SYRINGE DUE TO IT HAVING A BLACK SPEC INSIDE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893590 ↗
• MalfunctionJun 24, 2022Unexpected Color; Unexpected Color

  CUSTOMER NOTICED DISCOLORED SALINE PRIOR TO USE OF AQUASTAT 2T0806.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806837 ↗

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.,