OriGen Biomedical, Inc.
Medical device manufacturer in Austin, TX.
4510(k) clearances
0PMA approvals
19recalls
Device types
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1068-2024 Class II | Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing…Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design… | 12/19/2023Open, Classified |
| Z-1409-2021 Class III | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of…It was identified that tissue culture bags were incorrectly labeled as free of phthalates. | 01/28/2021Terminated |
| Z-0318-2021 Class II | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx OnlyThe firm has become aware that they have distributed product that was expired. | 06/24/2019Terminated |
| Z-0184-2019 Class II | Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0183-2019 Class II | ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0182-2019 Class II | Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0181-2019 Class II | Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0180-2019 Class II | Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0179-2019 Class II | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual…These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip… | 08/21/2018Terminated |
| Z-0102-2019 Class II | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual…The catheter failed the endotoxin testing. | 08/21/2018Terminated |
| Z-0021-2018 Class I | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire…Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a… | 08/02/2017Terminated |
| Z-1232-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1231-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1230-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1229-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1228-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1227-2019 Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16FClamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond… | 01/17/2017Terminated |
| Z-1456-2015 Class I | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE…Potential for clear extension tube to separate from the hub, which could result in blood loss and may… | 03/30/2015Terminated |
| Z-0269-2019 Class I | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE…Potential for clear extension tube to separate from the hub, which could result in blood loss and may… | 03/30/2015Terminated |