The Recall Desk
ModerateFDA (Devices)·Z-1605-2022·Announced 2022-08-31

Hydrogen Peroxide Disinfectant Recalled for Potential Loss of Effectiveness

Revital-Ox Resert hydrogen peroxide disinfectant 4-liter containers may have reduced effectiveness due to temperature exposure during storage. McKesson is recalling affected lots distributed June-September 2021.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a precautionary FDA Class II medical device recall based on potential loss of disinfectant effectiveness due to temperature exposure during storage and shipment. No illnesses, injuries, or confirmed product failures have been reported.

Plain-English summary

Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant, a 4-liter container product used in medical and healthcare settings, is being recalled by McKesson Medical-Surgical Inc. due to potential loss of effectiveness.

Between June and August 2021, products destined for distribution experienced temperature excursions at the manufacturing facility prior to shipment. This exposure to higher-than-recommended temperatures may have degraded the product's disinfecting properties, potentially reducing its effectiveness.

The recall affects all lots of this product received between June 1, 2021 and September 30, 2021. The affected product has the model number 4455AW and GTIN codes 00724995095017 and 50724995095012. Products were distributed nationwide in the United States.

Healthcare facilities and medical professionals who have received affected lots should discontinue use and consult with their infection control specialists and McKesson regarding appropriate replacement disinfectants.

The recalled product

Product
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
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • reduced-efficacy
  • temperature-degradation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • GTIN: 00724995095017
  • 50724995095012

Distribution

Distributed nationwide across the United States.