Approach CTO-6 and Hydro ST Microwire Guide With Hydrophylic Coating
Brand(s)
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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