[Recalled] ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure — AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due t… | FDA 2017-03-16
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure |
|---|---|
| Brand / manufacturer | Windstone Medical Packaging, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1789-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 16 March 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
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.