[Recalled] CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures. — A manufacturing error may cause the radiopaque marker bands to be too loose on… | FDA 2019
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures. |
|---|---|
| Brand / manufacturer | Cook Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0590-2020 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 08 November 2019 |
| EAN / barcode | 00827002515772 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
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.