[Recalled] Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vas
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications. |
|---|---|
| Brand / manufacturer | Cook Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0399-2021 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 22 October 2020 |
| EAN / barcode | 13199931 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
This Class I 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
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
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.