[Recalled] Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519 — The Medtronic COVER LIGHT HANDLE DISPOSABLE…
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519 |
|---|---|
| Brand / manufacturer | Windstone Medical Packaging, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1269-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 January 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
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 Windstone Medical Packaging, 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.
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