FDA Enforcement
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.
Recall: Z-1794-2022
·
Reported October 5, 2022
Enforcement
- Recall Number
- Z-1794-2022
- Event ID
- 90731
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- October 5, 2022
- Initiation Date
- May 25, 2022
- Classification Date
- September 26, 2022
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States
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
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.
Code Info
GTIN: a. 00707387508296; 00707387457037; 50707387508291; 30707387508297; 30707387457038. b. 50707387788006; 30707387788002; 00707387788001.
Distribution
US Nationwide distribution.
Quantity
a. 12 bags, b. 4 bags