Class I — OriGen Biomedical, Inc.
| Recalling firm | ORIGEN BIOMEDICAL, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 51 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands. |
| Initiated | 2015-03-30 |
| Classified | 2015-04-23 |
| Terminated | 2016-05-03 |
| Recall number | Z-1456-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — OriGen Biomedical, Inc. (Z-1456-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70988/
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