[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Wire Guide, Guidewire, Global Product Number G14326 |
|---|---|
| Brand / manufacturer | Cook Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0964-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 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 →
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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.