[Recalled] Thin-Flex Venous Cannula, Model Number:TF292902A — Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula… | FDA 2015-11-04
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Thin-Flex Venous Cannula, Model Number:TF292902A |
|---|---|
| Brand / manufacturer | Edwards Lifesciences, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0398-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 November 2015 |
| EAN / barcode | 59384061 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
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 Edwards Lifesciences, LLC
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.