Z-0813-2023 Class II Ongoing

Recalled by Biomerieux Inc — Hazelwood, MO

FDA device recall Z-0813-2023 was initiated by Biomerieux Inc on Nov 9, 2022 and is designated Class II. Reason for recall: As the temperature and time out of range was exceeded, product performances cannot be guaranteed The recall status is ongoing. Affected quantity: 4 units.

Recall Details

Product Type
Devices
Report Date
Jan 11, 2023
Initiation Date
Nov 9, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849

Reason for Recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Distribution Pattern

US Nationwide distribution.

Code Information

UDI/DI 03573026357849, Batch Numbers: 2117760, 2120100

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0813-2023
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.