Home / Recalls / OriGen Biomedical, Inc. / Z-1409-2021

Z-1409-2021 Class III Terminated

Recalled by OriGen Biomedical, Inc. — Austin, TX

Recall Details

Product Type
Devices
Report Date
April 21, 2021
Initiation Date
January 28, 2021
Termination Date
April 19, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1201 units

Product Description

Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

Reason for Recall

It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

Distribution Pattern

US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None

Code Information

All Lots

Other recalls by OriGen Biomedical, Inc.

  • Z-1068-2024 Class II — Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tub (December 19, 2023)
  • Z-0318-2021 Class II — 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, (June 24, 2019)
  • Z-0184-2019 Class II — Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: Th (August 21, 2018)
  • Z-0183-2019 Class II — ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications (August 21, 2018)
  • Z-0182-2019 Class II — Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The (August 21, 2018)
  • Z-0102-2019 Class II — Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforce (August 21, 2018)
  • Z-0181-2019 Class II — Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: Th (August 21, 2018)
  • Z-0179-2019 Class II — Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforce (August 21, 2018)
  • Z-0180-2019 Class II — Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The (August 21, 2018)
  • Z-0021-2018 Class I — The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a (August 2, 2017)