FDA Device recall Z-0318-2021
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
- FDA Device
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only by Origen Biomedical, citing the firm has become aware that they have distributed product that was expired.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0318-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-24 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Origen Biomedical |
| Distribution | TX |
Product
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Reason
The firm has become aware that they have distributed product that was expired.
Identifiers
| code_info | Lot # 042417-5045 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2021%22
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