PlainRecalls

OriGen Biomedical, Inc.

15 recalls on record · Latest: Feb 21, 2024

FDA Devices Moderate Feb 21, 2024

Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed …

FDA Devices Low Apr 21, 2021

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 …

FDA Devices Moderate Nov 11, 2020

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

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

FDA Devices Critical Nov 14, 2018

REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicat…

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a sing…

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a singl…

FDA Devices Moderate Oct 24, 2018

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

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a singl…

FDA Devices Moderate Oct 24, 2018

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

FDA Devices Moderate Oct 24, 2018

ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a …

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a sing…

FDA Devices Critical Apr 29, 2015

OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Rein…