[Recalled] SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device. — L
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device. |
|---|---|
| Brand / manufacturer | Medline Industries Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2043-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 28 May 2019 |
| EAN / barcode | 40080196848837 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Loose silicone particulate was found to be present on the shaft of the silicone 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 Medline Industries 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.