medical Class I Updated 2019-06-12

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

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: NY, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM

Lot/Code Info: Lots: N18447-1A, P18909, P18971

View official government recall

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