🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: June 24, 2016 Cook Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cook Inc.
Reason for Recall:
Potential coating contamination with glass particles.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2537-2016

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