Food, drugs, devices › OriGen Biomedical, Inc.
Device recall: REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen
FDA enforcement event 81164 is a device recall by OriGen Biomedical, Inc. of Austin, TX, initiated 30 Mar 2015 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 1 Mar 2024. Initiation: voluntary: firm initiated. OriGen Biomedical, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
OriGen Biomedical, Inc., Austin, TX.
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"
Distribution
"Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0269-2019 | 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… | 134 | Class I | Terminated | 14 Nov 2018 |
Context
Other enforcement events for OriGen Biomedical, Inc.
All 9 events for OriGen Biomedical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Mar 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.