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
Get notified
Receive notifications for new and updated recalls and alerts by category.