HUDSON RCI IPN049200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704628145), received between Apr 23, 2021 and Dec 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

1 other recall cover devices cleared under the same FDA submission (K142153); 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 18, 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.

• Dec 3, 2021Off-Label Use

  CONSUMER HAS BEEN USING ADDIPAK SINGLE USE 5 ML STERILE 0.9% NACL WITH THEIR SCLERAL HARD CONTACT LENSES, FOR A FEW YEARS WITHOUT ISSUE. THE CONSUMERS DOCTOR RECOMMENDED THE USE OF THIS PRODUCT IN AN OFF-LABEL MANNER. THE CONSUMER PURCHASED 2 NEW BOXES OF ADDIPAK IN LATE (B)(6) 2021 AND BEGAN USE OF THE NEW BOXES IN (B)(6) 2021. UPON THE FIRST USE OF THE ADDIPAK SALINE FROM THE NEW BOXES/LOT THE CONSUMER STATED THEY NOTED AN IMMEDIATE BURNING AND EYE IRRITANT, LIKE A CHEMICAL REACTION. COMPLAINT # (B)(4).

  Patient problems: Burning Sensation; Eye Burn

  MAUDE report 12933998 ↗
• MalfunctionApr 23, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "ITEM CAUSED ITCHING AND BURNING". UNKNOWN IF PATIENT HAD PREVIOUS ALLERGIES. NO HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Itching Sensation

  MAUDE report 11712725 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142153. One submission often covers many models, so check the product and lot details in each record.

• Z-2514-2023 · Aug 4, 2023 · Open, Classified
  HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U