Home / Recalls / OriGen Biomedical, Inc. / Z-0102-2019

Z-0102-2019 Class II Terminated

Recalled by OriGen Biomedical, Inc. — Austin, TX

Recall Details

Product Type
Devices
Report Date
October 24, 2018
Initiation Date
August 21, 2018
Termination Date
October 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
106

Product Description

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

Reason for Recall

The catheter failed the endotoxin testing.

Distribution Pattern

US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand

Code Information

UDI: 00816203022059, lot N18687-1

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-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-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-0184-2019 Class II — Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: Th (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)