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OriGen Biomedical, Inc. recalls REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The Or
Recalled November 14, 2018 · FDA recall Z-0269-2019 · OriGen Biomedical
Hazard
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage · FDA Class I
Units
134
Sold at
Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom
Description
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Product
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Manufacturer(s)
OriGen Biomedical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →