REF VV19F Reinforced Dual Lumen Cannula — Class I medical device recall Z-0269-2019
Terminated recall by OriGen Biomedical, Inc., reported 2018-11-14, distributed nationwide. Potential for clear extension tube to separate from the hub, which could result in blood loss and may require
| Recall number | Z-0269-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OriGen Biomedical, Inc., Austin, TX, United States |
| Recall initiated | 2015-03-30 |
| Classified | 2018-11-07 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2024-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, DE, ES, GB, PL, SA, SE, TH |
| Quantity | 134 |
| UPC / GTIN / UDI-DI | 00816203022097 |
| Lot numbers | N18394, VV19F |
| Model numbers | VV19F |
Product
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Reason for recall
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
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-0269-2019. 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.