OriGen Biomedical Inc.

• 4-Way Stopcock SC-1 Ref SC-1

  Class I FDA UDI

• Evolve EV120 + F-M12 Ref EV120 + F-M12

  Class I FDA UDI Active

• O-Wrap OW1430T Ref OW1430T

  Class I FDA UDI

• Cryostore CS500S Ref CS500S

  Class II FDA UDI

• Catheter w/ Blunt Introducer VV13F Ref VV13F

  Class II FDA UDI

• Cryostore CS500F1S Ref CS500F1S

  Class II FDA UDI

• Sterile Syringe 15-R30F-T Ref 15-R30F-T

  Class I FDA UDI

• Accessories VSV Ref VSV

  Class I FDA UDI

• PermaLife PL120T Ref PL120T

  Unclassified FDA UDI

• Cryobag CB1016 Ref CB1016

  Unclassified FDA UDI

• Spike Adapter S-38B12 Ref S-38B12

  Class I FDA UDI Active

• Cryostore CS1000NSW Ref CS1000NSW

  Class II FDA UDI

• Accessories 15-R6F-TA Ref 15-R6F-TA

  Class I FDA UDI Active

• Cryostore CS250FS Ref CS250FS

  Class II FDA UDI

• OriGen Biomedical CC3 Ref CC3

  Class I FDA UDI

• Catheter w/ Blunt Introducer VV32F Ref VV32F

  Class II FDA UDI

• Cryobag CB0915 Ref CB0915

  Unclassified FDA UDI

• Catheter w/ Blunt Introducer VV28F Ref VV28F

  Class II FDA UDI

• Cryostore CS50V4SW Ref CS50V4SW

  Class II FDA UDI

• Accessories 15-R3FT Ref 15-R3FT

  Class I FDA UDI

• PermaLife PL500P Ref PL500P

  Unclassified FDA UDI

• Spike Adapter S-M50C Ref S-M50C

  Class I FDA UDI

• Cryobag CB1420 Ref CB1420

  Unclassified FDA UDI

• Cryostore CS2000Y5 Ref CS2000Y5

  Class II FDA UDI

• Cell Connect CC35-5MT Ref CC35-5MT

  Class I FDA UDI

• Cryostore CS1000Y4S Ref CS1000Y4S

  Class II FDA UDI

• PermaLife PL2000P Ref PL2000P

  Unclassified FDA UDI

• Cryostore CS500i2PW Ref CS500i2PW

  Class II FDA UDI

• Female to Female Adapter F2F Ref F2F

  Class I FDA UDI

• TissueVault TV1936 Ref TV1936

  Class I FDA UDI

• CryoStore CS250F21P Ref CS250F21P

  Class II FDA UDI

• Cryostore CS250Y12S Ref CS250Y12S

  Class II FDA UDI

• Cryostore CS750Y10 Ref CS750Y10

  Class II FDA UDI

• Cryostore CS25XN Ref CS25XN

  Class II FDA UDI Active

• Cryostore CS750F1S Ref CS750F1S

  Class II FDA UDI

• Cryostore CS50V2 Ref CS50V2

  Class II FDA UDI Active

• PermaLife PL70 Ref PL70

  Unclassified FDA UDI

• 60ml Syringe R60-CS Ref R60-CS

  Class I FDA UDI

• Cryostore CS750V4 Ref CS750V4

  Class II FDA UDI

• Cryostore CS28V Ref CS28V

  Class II FDA UDI Active

• Catheter w/ Blunt Introducer VV16F Ref VV16F

  Class II FDA UDI

• Cryostore CS500NP Ref CS500NP

  Class II FDA UDI

• Injection Spike IBS-B Ref IBS-B

  Class I FDA UDI

• Cryostore CS500V2P Ref CS500V2P

  Class II FDA UDI

• Cryobag CB1428 Ref CB1428

  Unclassified FDA UDI

• Cryostore CS1000V4 Ref CS1000V4

  Class II FDA UDI

• Cryostore CS500F16 Ref CS500F16

  Class II FDA UDI

• Spike Adapter S-F50 Ref S-F50

  Class I FDA UDI Active

• Cryostore CS500i Ref CS500i

  Class II FDA UDI

• Percutaneous Kit PCTa Ref PCTa

  Class I FDA UDI

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

Country

United States

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