Health product recall

Approach CTO-6 and Hydro ST Microwire Guide With Hydrophylic Coating

Last updated

Summary

Product
Approach CTO-6 and Hydro ST Microwire Guide With Hydrophylic Coating
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Approach Hydro ST Microwire Guide With Hydrophylic Coating

15894225
15858389
15863267
15765951
15894224

HMW-14-190-ST
HMW-14-300-ST

Approach CTO-6 Microwire Guide

15835853
15885579
15718980
15891910
15891906
15802931
15835856
15802931X
15794896
15863270
15892397

CMW-14-300-18G
CMW-14-300-25G
CMW-14-190-18G

Issue

Devices from the affected device lots have labels that state the incorrect expiration dates. Preliminary investigation into this issue identified a calculation error occurred in Cook's labeling software, which uses a calculator to determine the correct expiration date. Due to this error, the calculator assigned the maximum potential shelf life to lots in scope rather than the actual shelf life.

Recall Start Date: October 8, 2024

Additional information

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

Cook, Incorporated

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

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76312

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