Cook Inc. recalls Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-…

Recall date

June 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2537-2016

FDA classification

Class I

Brand / firm

Cook Inc.

Sold / distributed

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

Why it was recalled

Potential coating contamination with glass particles.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.