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OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Recalled June 12, 2019 · FDA recall Z-1232-2019 · OriGen Biomedical
Hazard
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. · FDA Class I
Units
66
Sold at
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
Description
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.
Product
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Manufacturer(s)
OriGen Biomedical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →