OriGen Biomedical Inc.

• Cryostore CS250NSWT Ref CS250NSWT

  Class II FDA UDI

• PermaLife PL30J Ref PL30J

  Unclassified FDA UDI

• Cryostore CS50S-3 Ref CS50S-3

  Class II FDA UDI

• PermaLife PL750 Ref PL750

  Unclassified FDA UDI

• Cryostore CS250F5 Ref CS250F5

  Class II FDA UDI

• Cryostore CS50V9 Ref CS50V9

  Class II FDA UDI

• PermaLife PL325 Ref PL325

  Unclassified FDA UDI

• Cryostore CS750V3 Ref CS750V3

  Class II FDA UDI

• Cryostore CS250F4S Ref CS250F4S

  Class II FDA UDI

• PermaLife™ Cell Culture Bag PL30-2G Ref PL30-2G

  Unclassified FDA UDI

• Cryostore CS500i2 Ref CS500i2

  Class II FDA UDI

• PermaLife PL120 Ref PL120

  Unclassified FDA UDI

• Cryostore CS750V3S Ref CS750V3S

  Class II FDA UDI

• Cryostore CS500V3S Ref CS500V3S

  Class II FDA UDI

• PermaLife PL325L Ref PL325L

  Unclassified FDA UDI

• Spike Adapter S-S50 Ref S-S50

  Class I FDA UDI

• Cryobag CB1936 Ref CB1936

  Unclassified FDA UDI

• Cryostore CS750F8 Ref CS750F8

  Class II FDA UDI

• PermaLife™ Cell Culture Bag PL70-2G Ref PL70-2G

  Unclassified FDA UDI

• Cryostore CS1000NS Ref CS1000NS

  Class II FDA UDI

• Evolve EV120 Ref EV120

  Class I FDA UDI

• Adapter Tube Set, Large Bore HFT Ref HFT

  Class I FDA UDI

• Cryostore CS750M2 Ref CS750M2

  Class II FDA UDI

• Tube Adapter 15-F-T Ref 15-F-T

  Class I FDA UDI Active

• Accessory Set 30-P-6M Ref 30-P-6M

  Class I FDA UDI

• Cryostore CS50Y3 Ref CS50Y3

  Class II FDA UDI

• CryoStore CS250S Ref CS250S

  Class II FDA UDI

• Cryostore CS50N Ref CS50N

  Class II FDA UDI Active

• Cell Connect CC1 Ref CC1

  Class I FDA UDI Active

• Cryostore CS500NSWT Ref CS500NSWT

  Class II FDA UDI

• Cryostore CS25N Ref CS25N

  Class II FDA UDI Active

• TubeSet Adapter 2M-M17 Ref 2M-M17

  Class I FDA UDI

• Spike Adapter S-M10 Ref S-M10

  Class I FDA UDI

• Cryostore CS250F7P Ref CS250F7P

  Class II FDA UDI

• Evolve Cell Culture Bag EV120 + F-M12 Ref EV120 + F-M12

  Class I FDA UDI

• Cryostore CS50 Ref CS50

  Class II FDA UDI Active

• Cryostore CS28F Ref CS28F

  Class II FDA UDI

• Manifold Set SDv-9M141 Ref SDv-9M141

  Class I FDA UDI

• PermaLife PL325-4G Ref PL325-4G

  Unclassified FDA UDI Active

• Cryostore CS2000aY8SW Ref CS2000aY8SW

  Class II FDA UDI

• Cryostore CS50NSW Ref CS50NSW

  Class II FDA UDI

• Cryostore CS500M4 Ref CS500M4

  Class II FDA UDI

• Cryostore CS25FP Ref CS25FP

  Class II FDA UDI Active

• Cryostore CS400 Ref CS400

  Class II FDA UDI

• Cryostore CS750F5-2 Ref CS750F5-2

  Class II FDA UDI

• PermaLife™ Cell Culture Bag PL30M Ref PL30M

  Unclassified FDA UDI Active

• Cryostore CS750NSWT Ref CS750NSWT

  Class II FDA UDI

• Catheter w/ Blunt Introducer VV23F Ref VV23F

  Class II FDA UDI

• PermaLife PL2000P2 Ref PL2000P2

  Unclassified FDA UDI

• Cryostore CS50SW Ref CS50SW

  Class II 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

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