Health product recall

Roadrunner Guidewire

Brand(s)
Last updated

Summary

Product
Roadrunner Guidewire
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Roadrunner Uniglide Hydrophilic Wire Guide

More than 10 numbers, contact manufacturer.

HPW-18-150
HPWAS-35-150
HPW-35-150

Roadrunner Pc Guidewire

More than 10 numbers, contact manufacturer.

RLPC-35-180
RFSPC-35-180

Issue

Cook Medical identified that samples from the affected device lots did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing. This failure was traced to material that is supplied to Cook Medical from an external supplier.

Recall start date: July 19, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Cook, Inc.

750 Daniels Way, Bloomington, Indiana, United States, 47404

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64401

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