PlainRecalls
FDA Devices Low Class III Ongoing

a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.

Reported: October 5, 2022 Initiated: May 25, 2022 #Z-1794-2022

Product Description

a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.

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
a. 12 bags, b. 4 bags
Distribution
US Nationwide distribution.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: a. 12 bags, b. 4 bags.
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 October 5, 2022. Severity: Low. Recall number: Z-1794-2022.