Home / Recalls / OriGen Biomedical, Inc. / Z-0318-2021

Z-0318-2021 Class II Terminated

Recalled by OriGen Biomedical, Inc. — Austin, TX

Recall Details

Product Type
Devices
Report Date
November 11, 2020
Initiation Date
June 24, 2019
Termination Date
July 14, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

Reason for Recall

The firm has become aware that they have distributed product that was expired.

Distribution Pattern

US: TX

Code Information

Lot # 042417-5045

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-1409-2021 Class III — Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag i (January 28, 2021)
  • 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)