Z-2537-2016 Class I Terminated
FDA device recall Z-2537-2016 was initiated by Cook Inc. on Jun 24, 2016 and is designated Class I. Reason for recall: Potential coating contamination with glass particles. The recall status is terminated (terminated Nov 1, 2017). Affected quantity: 8,750 devices were distributed in commerce.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2016
- Initiation Date
- Jun 24, 2016
- Termination Date
- Nov 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,750 devices were distributed in commerce
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.
Reason for Recall
Potential coating contamination with glass particles.
Distribution Pattern
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
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2537-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026