PlainRecalls
FDA Devices Moderate Class II Ongoing

STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW

Reported: August 31, 2022 Initiated: May 25, 2022 #Z-1605-2022

Product Description

STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW

Reason for Recall

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Details

Units Affected
20.25 CS
Distribution
US Nationwide
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 20.25 CS.
Why was this product recalled?
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1605-2022.