FDA Enforcement
Class II
Ongoing
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Recall: Z-1838-2025
·
Reported June 4, 2025
Enforcement
- Recall Number
- Z-1838-2025
- Event ID
- 96752
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 4, 2025
- Initiation Date
- April 24, 2025
- Classification Date
- May 27, 2025
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States
Description
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Reason
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Code Info
Catalog No. 171001002; GTIN: 8718734960300; Order No. 46085136.
Distribution
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Quantity
1 unit