Home / Recalls / OriGen Biomedical, Inc. / Z-1228-2019

Z-1228-2019 Class I Terminated

Recalled by OriGen Biomedical, Inc. — Austin, TX

Recall Details

Product Type
Devices
Report Date
June 12, 2019
Initiation Date
January 17, 2017
Termination Date
July 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72

Product Description

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F

Reason for Recall

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Distribution Pattern

US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile

Code Information

Lots: N18431, N18431-1, R19280, R19281

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)