Home / Recalls / OriGen Biomedical, Inc. / Z-0021-2018

Z-0021-2018 Class I Terminated

Recalled by OriGen Biomedical, Inc. — Austin, TX

Recall Details

Product Type
Devices
Report Date
November 1, 2017
Initiation Date
August 2, 2017
Termination Date
February 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 units

Product Description

The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Reason for Recall

Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).

Distribution Pattern

US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.

Code Information

Lot Numbers: N18487, N18487-1

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-0318-2021 Class II — 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, (June 24, 2019)
  • 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-0102-2019 Class II — Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforce (August 21, 2018)
  • Z-0182-2019 Class II — Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The (August 21, 2018)
  • Z-0183-2019 Class II — ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications (August 21, 2018)
  • Z-0184-2019 Class II — Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: Th (August 21, 2018)
  • Z-0180-2019 Class II — Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The (August 21, 2018)