Reinforced Dual Lumen Cannula — Class II medical device recall Z-0180-2019
Terminated recall by OriGen Biomedical, Inc., reported 2018-10-24, distributed nationwide. These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip le
| Recall number | Z-0180-2019 |
|---|---|
| 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 | 2018-10-18 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2021-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, CA, CO, DE, GB, IN, IT, JP, NL, NZ, PL, QA, RO, SA, SE, TH, VN, ZA |
| Quantity | 452 |
| UPC / GTIN / UDI-DI | 00816203022073 |
| Lot numbers | N18404, N18446, N18640, N18640-1, R19208 |
| Model numbers | VV16F |
Product
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
Reason for recall
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
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-0180-2019. 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.