OriGen Biomedical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0102-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 21, 2018

Date Posted: October 24, 2018

Recall Number: Z-0102-2019

Event ID: 81098

Reason for Recall:

The catheter failed the endotoxin testing.

Status: Terminated

Product Quantity: 106

Code Information:

UDI: 00816203022059, lot N18687-1

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

Voluntary or Mandated:

Voluntary: Firm initiated