FDA-Device2019-06-12Class I
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
OriGen Biomedical, Inc.
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.
Sold states
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
Affected count
260
Manufactured in
7000 Burleson Rd Bldg D, Austin, TX, United States
Products
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1227-2019Don't want to check this manually?
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