[Recalled] MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiolo
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product co |
|---|---|
| Brand / manufacturer | Avanos Medical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2422-2024 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 31 May 2024 |
| EAN / barcode | 00350770472171 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
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 →
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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.