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FDA (Device enforcement)Recalled 2022-05-25class ii

Mckesson Medical-Surgical Inc. Corporate Office: a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISI

Is my product affected?

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% 28DAY QT (16/CS) PSS744 Catalo

  • UPC 10612479150581
  • UPC 40612479150599
  • UPC 10612479150567
  • UPC 40612479150575
  • UPC 10612479204406
  • UPC 40612479204414
  • UPC 00615375005453
  • UPC 10615375005450
  • UPC 00615375005477
  • UPC 10615375005474

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling glutaraldehyde disinfectant products sold under the McKesson and Metrex Research brands. The products were exposed to higher than normal temperatures at a facility between June and August 2021 before being delivered to customers. This temperature exposure may have reduced the effectiveness of the disinfectants. The recall affects all lots of these products received between June 1, 2021 and September 30, 2021, distributed nationwide in quantities ranging from 16 quarts to 124 gallons, depending on the specific product.

The recalled products include McKesson Disinfectant Glutaraldehyde 28 Day and Metrex Research 14-Day Glutaraldehyde Solution in various container sizes. Affected consumers can identify recalled products by checking the lot and code numbers listed in the recall notice. The source document does not specify a remedy or recommended course of action for consumers who have purchased these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. Distribution: US Nationwide Quantity: 28 gallons b. 38 gal c. 16 qt d. 40 gal e. 124 gal Lot/code info: GTIN: a. 10612479150581; 40612479150599 CS. b. 10612479150567; 40612479150575 CS. c. 10612479204406; 40612479204414. d. 00615375005453; 10615375005450 CS; H9711014002. e. 00615375005477; 10615375005474 CS; H97110280022

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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