OriGen Biomedical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1231-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: January 17, 2017

Date Posted: June 12, 2019

Recall Number: Z-1231-2019

Event ID: 82512

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.

Status: Terminated

Product Quantity: 61

Code Information:

Lots: N18447-1A, P18909, P18971

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

Voluntary or Mandated:

Voluntary: Firm initiated