The Recall Desk
ModerateFDA (Devices)·Z-1614-2022·Announced 2022-08-31

McKesson and Metrex Research Glutaraldehyde Disinfectants Recalled Due to Temperature Excursion

McKesson and Metrex Research are recalling glutaraldehyde disinfectants due to facility temperature excursions from June to August 2021 that may have reduced product effectiveness. Affected lots were distributed nationwide between June 1 and September 30, 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 Class II recall of medical device disinfectants where facility temperature excursions may have reduced product effectiveness. No illnesses, injuries, or confirmed product failures have been reported, and the hazard is theoretical rather than confirmed, qualifying this as a precautionary voluntary recall.

Plain-English summary

McKesson Medical-Surgical Inc. and Metrex Research are recalling multiple glutaraldehyde disinfectant products, including McKesson Disinfectant (Glutaraldehyde 28-Day and 14-Day formulations), Metrex Research Solution (Glut 2.5% 28-Day), and MetriCide disinfectants (14-Day and Long-Life formulations). These products are used in medical and surgical settings for high-level disinfection and sterilization of medical equipment and instruments.

The recall was issued because facility temperature excursions occurred between June 2021 and August 2021 prior to product delivery. Exposure to higher-than-appropriate temperatures may have impacted the chemical effectiveness of the disinfectant solutions, potentially compromising their ability to properly disinfect and sterilize medical equipment.

All lots of the affected products distributed in the United States between June 1, 2021, and September 30, 2021, are included in this recall. The products were distributed nationwide.

Healthcare facilities and consumers who have purchased these products should discontinue use and contact McKesson Medical-Surgical Inc. for information regarding product return or replacement.

The recalled product

Product
a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5%
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • temperature-damage
  • reduced-effectiveness

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 (8)

  • GTIN: a. 10612479150581
  • 40612479150599 CS. b. 10612479150567
  • 40612479150575 CS. c. 10612479204406
  • 40612479204414. d. 00615375005453
  • 10615375005450 CS
  • H9711014002. e. 00615375005477
  • 10615375005474 CS
  • H97110280022

Distribution

Distributed nationwide across the United States.