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 |
Roadrunner Pc Guidewire |
More than 10 numbers, contact manufacturer. |
RLPC-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: 2022-07-27
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