PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
FDA Recall #Z-0803-2023 — Class II — November 9, 2022
Product Description
PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
Reason for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Recalling Firm
Biomerieux Inc — Hazelwood, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026313128, Batch Numbers: 1009540400
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.