Recall · FDA
Windstone Medical Packaging, Inc.
Windstone Medical Packaging, Inc. issued a Class II FDA recall (Z-1267-2017) initiated 2017-01-11: Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS183…
| Company | Windstone Medical Packaging, Inc. |
|---|---|
| Recall number | Z-1267-2017 |
| Classification | Class II |
| Status | Terminated |
| Category | Devices |
| Initiated | 2017-01-11 |
| Product | Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A |
| Reason | 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. |
FAQ
What did Windstone Medical Packaging, Inc. recall?
Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
Why was Windstone Medical Packaging, Inc.'s product recalled?
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.