PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
FDA Recall #Z-0875-2023 — Class II — November 9, 2022
Product Description
PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
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
12 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 03573026320706, Batch Numbers: 1009497920
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated