OriGen Biomedical Inc.

• Cryostore CS500 Ref CS500

  Class II FDA UDI Active

• Cryostore CS250F1A Ref CS250F1A

  Class II FDA UDI

• Cryostore CS50-3 Ref CS50-3

  Class II FDA UDI

• Spike Adapter F-8S100 Ref F-8S100

  Class I FDA UDI Active

• Cryostore CS750F5 Ref CS750F5

  Class II FDA UDI

• Cryostore CS750M2S Ref CS750M2S

  Class II FDA UDI

• CryoStore Freezing Bag CS25XN Ref CS25XN

  Class II FDA UDI

• Cryostore CS25Y2 Ref CS25Y2

  Class II FDA UDI

• Cryostore CS1950aY8SW Ref CS1950aY8SW

  Class II FDA UDI

• Spike Adapter S-F15 Ref S-F15

  Class I FDA UDI

• Cryostore CS250i2PW Ref CS250i2PW

  Class II FDA UDI

• Cryostore CS750M2SW Ref CS750M2SW

  Class II FDA UDI

• PermaLife PL240 Ref PL240

  Unclassified FDA UDI

• PermaLife PL07J Ref PL07J

  Unclassified FDA UDI

• Cryostore CS750Y11 Ref CS750Y11

  Class II FDA UDI

• Manifold Set 4S-4M60 Ref 4S-4M60

  Class I FDA UDI Active

• TissueVault™ Cell & Tissue Freezing Bag TV0909 Ref TV0909

  Class I FDA UDI Active

• CryoStore Freezing Bag CS30M9 Ref CS30M9

  Class II FDA UDI Active

• TubeSet Adapter 2M-F17 Ref 2M-F17

  Class I FDA UDI

• Spike Adapter 150-S-M Ref 150-S-M

  Class I FDA UDI Active

• CryoStore CS2000V8S Ref CS2000V8S

  Class II FDA UDI

• Cryostore CS250S Ref CS250S

  Class II FDA UDI Active

• Cryostore CS25M5 Ref CS25M5

  Class II FDA UDI

• Tube Set 30-T-SPF Ref 30-T-SPF

  Class I FDA UDI

• Injection Spike IBS-X Ref IBS-X

  Class I FDA UDI

• Cryostore CS50V8S Ref CS50V8S

  Class II FDA UDI

• Spike Tube Set Adapter S-FFP12 Ref S-FFP12

  Class I FDA UDI Active

• Cryostore CS500V3 Ref CS500V3

  Class II FDA UDI

• Cryostore CS250 Ref CS250

  Class II FDA UDI Active

• Cryostore CS50H Ref CS50H

  Class II FDA UDI

• PermaLife PL325P Ref PL325P

  Unclassified FDA UDI

• TubeSet Adapter 24-T-3T Ref 24-T-3T

  Class I FDA UDI

• Cryostore CS50F15 Ref CS50F15

  Class II FDA UDI

• Accessory Set 2S-9M141 Ref 2S-9M141

  Class I FDA UDI

• Cryostore CS250F7 Ref CS250F7

  Class II FDA UDI

• Protective Cap PC2-B Ref PC2-B

  Class I FDA UDI

• TubeSet Adapter 4S-M40 Ref 4S-M40

  Class I FDA UDI

• Accessories IBS Ref IBS

  Class I FDA UDI

• 3ml Syringe, FLL X SCD 15-R3FT Ref 15-R3FT

  Class I FDA UDI Active

• Accessory Set 45-F-9M Ref 45-F-9M

  Class I FDA UDI

• NFV x SCD 50ml Syringe RV50-T15 Ref RV50-T15

  Class I FDA UDI

• O-Wrap OW0419 Ref OW0419

  Class I FDA UDI

• 3ml Syringe, FLL X SCD R3F-T15 Ref R3F-T15

  Class I FDA UDI Active

• CryoStore 25 Freezing Bag Ref CS25Y4

  Class IIa EUDAMEDFDA UDI Active

• PermaLife™ Cell Culture Bag Ref PL240T

  Class IIa EUDAMEDFDA UDI Active

• CryoStore FLEX Bag Ref CS20NS

  Class IIa EUDAMEDFDA UDI Active

• TissueVault™ Cell & Tissue Freezing Bag Ref TV0918

  Class IIa EUDAMEDFDA UDI Active

• Spike Adapters Ref 2S-P20

  Class IIa EUDAMEDFDA UDI Active

• CryoStore Freezing Bags Ref CS750N

  Class IIa EUDAMEDFDA UDI Active

• CryoStore FLEX Bag Ref CS20F

  Class IIa EUDAMEDFDA 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