[Recalled] Basic Face Kit, part number PS517A(D — The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medica… | FDA 2017-01-11
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Basic Face Kit, part number PS517A(D |
|---|---|
| Brand / manufacturer | Windstone Medical Packaging, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1265-2017 |
| 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.