3/8" FloPump — Class II medical device recall Z-0318-2021
Terminated recall by OriGen Biomedical, Inc., reported 2020-11-11, distributed in TX. The firm has become aware that they have distributed product that was expired.
| Recall number | Z-0318-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OriGen Biomedical, Inc., Austin, TX, United States |
| Recall initiated | 2019-06-24 |
| Classified | 2020-10-30 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2021-07-14 |
| Distributed | TX |
| Quantity | 6 units |
| Lot numbers | 042417-5045 |
| Model numbers | 6400S |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0318-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.