OriGen Biomedical, Inc.
Austin, TX, US
OriGen Biomedical, Inc. appears in FDA device records in Austin, TX. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for OriGen Biomedical, Inc. between 2001 and 2012. The busiest year on record is 2001, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2002 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K113869 | ORIGEN REINFORCED DUAL LUMEN CATHETER | DWF | Substantially Equivalent | |
| K021702 | CRYOBAG, MODEL CB | LPZ | Substantially Equivalent | |
| K003288 | ORIGEN DUAL LUMEN CATHETER | DQO | Substantially Equivalent | |
| K003145 | ORIGEN BLADDER HOLDER | DWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1646848 | 1000160256 | OriGen Biomedical, Inc. | 7000 Burleson Rd. Bldg D, Austin, TX 78744 US | 2026 | |
| 3042484745 | 3042484745 | OriGen Biomedical, Inc. | 2215 Grand Avenue Pkwy, Austin, TX 78728 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DQOCatheter, Intravascular, Diagnostic
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- LPZContainer, Frozen Donor Tissue Storage
- FMHContainer, Specimen, Sterile
- DWCController, Temperature, Cardiopulmonary Bypass
- KSDDevice, Heat-Sealing
- KJAFlask, Tissue Culture
- KJGTube, Tissue Culture
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1068-2024 | Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T | Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes. | Class II | Open, Classified | |
| Z-1409-2021 | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. | Class III | Terminated | |
| Z-0318-2021 | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only | The firm has become aware that they have distributed product that was expired. | Class II | Terminated | |
| Z-0102-2019 | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO | The catheter failed the endotoxin testing. | Class II | Terminated | |
| Z-0184-2019 | Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, 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. | 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 | Class II | Terminated | |
| Z-0183-2019 | ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, 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. | 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 | Class II | Terminated | |
| Z-0182-2019 | Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, 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. | 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 | Class II | Terminated | |
| Z-0181-2019 | Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, 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. | 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 | Class II | Terminated | |
| Z-0180-2019 | 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. | 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 | Class II | Terminated | |
| Z-0179-2019 | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, 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. | 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 | Class II | Terminated | |
| Z-0021-2018 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. | Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss). | Class I | Terminated | |
| Z-1232-2019 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub. | Class I | Terminated | |
| Z-1231-2019 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub. | Class I | Terminated | |
| Z-1230-2019 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub. | Class I | Terminated | |
| Z-1229-2019 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub. | Class I | Terminated | |
| Z-1228-2019 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub. | Class I | Terminated | |
| Z-1227-2019 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub. | Class I | Terminated | |
| 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 hours or less. | 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 | Class I | Terminated | |
| Z-1456-2015 | 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. | 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. | Class I | Terminated | |
| Z-0055-06 | Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744 | Leak between two lumens causes reduced performance. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain