OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE… — Class I medical device recall Z-1456-2015
Terminated recall by OriGen Biomedical, Inc., reported 2015-04-29, distributed nationwide. Potential for clear extension tube to separate from the hub, which could result in blood loss and may require
| Recall number | Z-1456-2015 |
|---|---|
| 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 | 2015-04-23 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2016-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, GB, NL, SE |
| Quantity | 51 units |
| Lot numbers | N18549 |
Product
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter 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 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-1456-2015. 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.