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[Recalled] Wire Guide, Guidewire, Global Product Number G14326 — The wire guide may be incorrectly loaded into the wire guide holder, leading to… | FDA 2019-01-04

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductWire Guide, Guidewire, Global Product Number G14326
Brand / manufacturerCook Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0964-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date04 January 2019

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Cook Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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