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Sign in to claim this brandOriGen Biomedical, Inc.
United States·US-MF-000018098
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2215, Grand Avenue Parkway, Austin, United States
- Website
- www.origen.com/
- —
- —
- [email protected]
- Phone
- +1 512-474-7278
- PRRC Contact
- Sam Saleh
- EUDAMED SRN
- US-MF-000018098
- FDA FEI Number
- 1000160256
- DUNS Number
- —
Catalogue (263)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spike Adapters | CBS | EUDAMED | Class IIa | Active |
| PermaLife™ Cell Culture Bag | PL30T | EUDAMEDFDA UDI | Class IIa | Active |
| CryoStore 25 Freezing Bag | CS25XN | EUDAMED | Class IIa | Active |
| PermaLife™ Cell Culture Bag | PL120K | EUDAMEDFDA UDI | Class IIa | Active |
| Spike | IBS | EUDAMED | Class IIa | Active |
| PermaLife™ Cell Culture Bag | PL2000K | EUDAMEDFDA UDI | Class IIa | Active |
| PermaLife™ Cell Culture Bag | PL500P-2G | EUDAMEDFDA UDI | Class IIa | Active |
| Manifold Sets | F-8S100 | EUDAMED | Class IIa | Active |
| Spike Adapters | VSV | EUDAMED | Class I | Active |
| TissueVault™ Cell & Tissue Freezing Bag | TV0909 | EUDAMEDFDA UDI | Class IIa | Active |
| PermaLife™ Cell Culture Bag | PL30M | EUDAMEDFDA UDI | Class IIa | Active |
| CryoPur™ Solutions | CP-10 | EUDAMED | Class IIa | Active |
| PermaLife™ Cell Culture Bag | PL1000P | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Recalls (20)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 19, 2023 | Z-1068-2024 | — | open, classified | 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. |
| Jan 28, 2021 | Z-1409-2021 | — | terminated | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. |
| Jun 24, 2019 | Z-0318-2021 | — | terminated | The firm has become aware that they have distributed product that was expired. |
| Aug 21, 2018 | Z-0184-2019 | — | terminated | 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 |
| Aug 21, 2018 | Z-0181-2019 | — | terminated | 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 |
| Aug 21, 2018 | Z-0183-2019 | — | terminated | 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 |
| Aug 21, 2018 | Z-0102-2019 | — | terminated | The catheter failed the endotoxin testing. |
| Aug 21, 2018 | Z-0182-2019 | — | terminated | 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 |
| Aug 21, 2018 | Z-0179-2019 | — | terminated | 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 |
| Aug 21, 2018 | Z-0180-2019 | — | terminated | 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 |
| Aug 2, 2017 | Z-0021-2018 | — | terminated | 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). |
| Jan 17, 2017 | Z-1227-2019 | — | terminated | 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. |
| Jan 17, 2017 | Z-1231-2019 | — | terminated | 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. |
| Jan 17, 2017 | Z-1230-2019 | — | terminated | 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. |
| Jan 17, 2017 | Z-1228-2019 | — | terminated | 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. |
| Jan 17, 2017 | Z-1229-2019 | — | terminated | 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. |
| Jan 17, 2017 | Z-1232-2019 | — | terminated | 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. |
| Mar 30, 2015 | Z-1456-2015 | — | terminated | 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. |
| Mar 30, 2015 | Z-0269-2019 | — | terminated | 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 |
| Dec 16, 2002 | Z-0055-06 | — | terminated | Leak between two lumens causes reduced performance. |