OriGen Biomedical Inc.

• PermaLife PL07 Ref PL07

  Unclassified FDA UDI

• TubeSet Adapter F-S12 Ref F-S12

  Class I FDA UDI

• TubeSetAdapter 12-F-M Ref 12-F-M

  Class I FDA UDI

• 6ml Syringe, NFV x SCD RV-T15 Ref RV-T15

  Class I FDA UDI

• CryoBag CB10K2 Ref CB10K2

  Unclassified FDA UDI

• PVC Transfer Bag 10-200 Ref 10-200

  Class II FDA UDI

• Vial Spike with Needle-Free Valve VSV Ref VSV

  Class I FDA UDI Active

• Cryostore CS50F4S Ref CS50F4S

  Class II FDA UDI

• PVC Transfer Bag 10-200-2 Ref 10-200-2

  Class II FDA UDI

• Spike Adapter S-F10 Ref S-F10

  Class I FDA UDI Active

• Spike Adapter SU-M50 Ref SU-M50

  Class I FDA UDI

• Cryostore CS250F4 Ref CS250F4

  Class II FDA UDI

• Accessories 80HAS Ref 80HAS

  Class I FDA UDI Active

• Accessory Sets 15-T-FA Ref 15-T-FA

  Class I FDA UDI

• Evolve EV3000N Ref EV3000N

  Class I FDA UDI Active

• PermaLife PL30 Ref PL30

  Unclassified FDA UDI

• Accessory Sets 15-RF20-T Ref 15-RF20-T

  Class I FDA UDI Active

• Catheter w/ Blunt Introducer VV19F Ref VV19F

  Class II FDA UDI

• Cryostore CS50M3 Ref CS50M3

  Class II FDA UDI Active

• Cryostore CS25F Ref CS25F

  Class II FDA UDI Active

• Cryostore CS250F Ref CS250F

  Class II FDA UDI

• PVC Transfer Bag 10-200-CS25 Ref 10-200-CS25

  Class II FDA UDI

• Spike Adapter SM Ref SM

  Class I FDA UDI

• Cryostore CS2000NP Ref CS2000NP

  Class II FDA UDI

• Needle Free Spike CBS Ref CBS

  Class I FDA UDI Active

• Cryostore CS250SW Ref CS250SW

  Class II FDA UDI

• Cryostore CS500SW Ref CS500SW

  Class II FDA UDI

• Cryostore CS250Y12P Ref CS250Y12P

  Class II FDA UDI

• Female to Female Adapter F-M12 Ref F-M12

  Class I FDA UDI

• Cryostore CS25V2 Ref CS25V2

  Class II FDA UDI

• Cryostore CS2000 Ref CS2000

  Class II FDA UDI

• Evolve EV1000N Ref EV1000N

  Class I FDA UDI Active

• Spike Adapter 40-S-V-SMM Ref 40-S-V-SMM

  Class I FDA UDI

• Spike Adapter S-S10 Ref S-S10

  Class I FDA UDI Active

• Percutaneous Tray PCT Ref PCT

  Class I FDA UDI

• Cryostore CS25Y4 Ref CS25Y4

  Class II FDA UDI Active

• Cryostore CS50V4 Ref CS50V4

  Class II FDA UDI

• Cryostore Harvest Kit CS750Y12S Ref CS750Y12S

  Class II FDA UDI

• 12ml Syringe R12-C Ref R12-C

  Class I FDA UDI

• Triple Spike Adapter 3S-T100 Ref 3S-T100

  Class I FDA UDI

• Cell Conect CC2 Ref CC2

  Class I FDA UDI Active

• CryoStore CS500V8 Ref CS500V8

  Class II FDA UDI

• Cryostore CS250F1 Ref CS250F1

  Class II FDA UDI

• Injection Spike IBS Ref IBS

  Class I FDA UDI Active

• ABS Spike Adapter ST-A Ref ST-A

  Class I FDA UDI

• Cryostore CS1000V3 Ref CS1000V3

  Class II FDA UDI

• Accessory Sets 15-RF12-T Ref 15-RF12-T

  Class I FDA UDI Active

• Needle-Free Valves NFV Ref NFV

  Class I FDA UDI

• Two 4-way stopcocks SC-2 Ref SC-2

  Class I FDA UDI

• Spike Adapter S-M50 Ref S-M50

  Class I FDA UDI Active

Showing the 10 most recent of 20 recalls.

• 2023

  • 19 Dec 2023 Z-1068-2024 Class II Ongoing 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.via FDA establishment OriGen Biomedical, Inc.

• 2021

  • 28 Jan 2021 Z-1409-2021 Class III Terminated It was identified that tissue culture bags were incorrectly labeled as free of phthalates.via FDA establishment OriGen Biomedical, Inc.

• 2019

  • 24 Jun 2019 Z-0318-2021 Class II Terminated The firm has become aware that they have distributed product that was expired.via FDA establishment OriGen Biomedical, Inc.

• 2018

  • 21 Aug 2018 Z-0102-2019 Class II Terminated The catheter failed the endotoxin testing.via FDA establishment OriGen Biomedical, Inc.
  • 21 Aug 2018 Z-0179-2019 Class II 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 tipvia FDA establishment OriGen Biomedical, Inc.
  • 21 Aug 2018 Z-0180-2019 Class II 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 tipvia FDA establishment OriGen Biomedical, Inc.
  • 21 Aug 2018 Z-0181-2019 Class II 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 tipvia FDA establishment OriGen Biomedical, Inc.
  • 21 Aug 2018 Z-0182-2019 Class II 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 tipvia FDA establishment OriGen Biomedical, Inc.
  • 21 Aug 2018 Z-0183-2019 Class II 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 tipvia FDA establishment OriGen Biomedical, Inc.
  • 21 Aug 2018 Z-0184-2019 Class II 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 tipvia FDA establishment OriGen Biomedical, Inc.

• OriGen Biomedical, Inc. Austin, TX · US FEI 1000160256

Address

2215, Grand Avenue Parkway, Austin, United States

Website

www.origen.com/

LinkedIn

linkedin.com/company/origen-biomedical

Facebook

facebook.com/OriGenBiomedical

Email

[email protected]

Phone

+1 512-474-7278

PRRC contact

Sam Saleh

EUDAMED SRN

US-MF-000018098

FDA FEI number

3042484745

DUNS number

625272232