[Recalled] Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room — The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom… | FDA 2015-04-22
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room |
|---|---|
| Brand / manufacturer | Windstone Medical Packaging, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0260-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 April 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit 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.