Recall Z-2537-2016— Cook Inc.

Name: FDA recall Z-2537-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-24

Class I · Terminated

Class I FDA medical device recall by Cook Inc., initiated 2016-06-24, terminated 2017-11-01. It names 2 FDA 510(k) clearances: K130766, K110009. 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. 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: Potential coating contamination with glass particles..

Recalling firm: Cook Inc.
Classification: Class I
Status: Terminated
Initiated: 2016-06-24
Terminated: 2017-11-01
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K130766 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDECook, Inc.·cleared 2013-07-17
K110009 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDECook, Inc.·cleared 2011-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.