Device Recall Roadrunner Uniglide Hydrophilic Wire Guide

  • Model / Serial
    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177.   Lot numbers 6911522, 6911523, 6911524, 6911526, 6911527, 6911528, 6911529, 6911530, 6911533, 6911535, 6911545, 6911549, 6911551, 6911552, 6919676, 6919678, 6919680, 6935843, 6935844, 6935846, 6935848, 6935849, 6935850, 6935851, 6935852, 6935853, 6935855, 6948854, 6948855, 6948856, 6948857, 6948858, 6948860, 6948861, 6948862, 6955228, 6955229, 6955230, 6955231, 6955232, 6955233, 6955234, 6955235, 6955236, 6955237, 6961752, 6961753, 6961754, 6961755, 6961756, 6961757, 6961758, 6961759, 6961760, 6961761, 6965235, 6965236, 6965237, 6965238, 6965240, 6965469, 6965625, 6965626, 6968777, 6968779, 6975365, 6975367, 6975368, 6981022, 6981026, 6981346, 6981347, 6981349, 6981351, 6986896, 6986897, 6986898, 6988487, 6988488, 6992197, 6992198, 6995077, 6995078, 6995080, 6995082, 6995083, 6997860, 6999759, 6999760, 7000724, 7000725, 7000726, 7000727, 7000730, 7000732, 7000733, 7000735, 7012526, 7012527, 7012528, 7012529, 7012530, 7012840, 7015853, 7015854, 7015855, 7015856, 7015857, 7015897, 7015898, 7015899, 7016252, 7016253, 7019017, 7019018, 7019019, 7019020, 7019022, 7019025, 7019027, 7019491, 7019492, 7019493, 7019494, 7021222, 7021223, 7021224, 7021225, 7021226, 7021227, 7022591, 6948855X, 6955234X, NS6911520, NS6935845, NS6935847, NS6935854, NS6948859, NS6965239, NS6968778, NS6975369, NS6981025, NS6995079, NS6999757, NS6999758, NS6999761, NS7000728, NS7012841, NS7019023, NS7019024, and NS7019495.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom
  • Product Description
    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. || Used with vascular catheter. || Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
  • Source
    USFDA