Recall Z-1366-2017— Windstone Medical Packaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2017-01-11, terminated 2017-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Set Up Pack, part number PSS3574(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..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-11
- Terminated
- 2017-05-03
- Firm location
- Billings, MT, United States
Product description
Set Up Pack, part number PSS3574(A
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.