ECMO Reinforced Dual Lumen Cannula recalled over mold contamination

Recall date

January 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

Recall number

Z-1232-2019

FDA classification

Class I

Brand / firm

OriGen Biomedical, Inc.

Sold / distributed

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…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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