FDA recall Z-0318-2021
OriGen Biomedical, Inc. · Class II · device
Product
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Reason for recall
The firm has become aware that they have distributed product that was expired.
Distribution
US: TX
Key facts
- Status
- Terminated
- Initiation date
- 2019-06-24
- Report date
- 2020-11-11
- Termination date
- 2021-07-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Austin, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0318-2021