[Recalled] Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techni
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques. |
|---|---|
| Brand / manufacturer | Cook Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0467-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 October 2019 |
| EAN / barcode | 00827002107335 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
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.