Reinforced Dual Lumen Cannula — Class II medical device recall Z-0102-2019
Terminated recall by OriGen Biomedical, Inc., reported 2018-10-24, distributed nationwide. The catheter failed the endotoxin testing.
| Recall number | Z-0102-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OriGen Biomedical, Inc., Austin, TX, United States |
| Recall initiated | 2018-08-21 |
| Classified | 2018-10-12 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2021-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, NZ, SA, TH |
| Quantity | 106 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00816203022059 |
| Lot numbers | N18687-1 |
| Model numbers | VV13F |
Product
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Reason for recall
The catheter failed the endotoxin testing.
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-0102-2019. 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.