Recall Z-1357-2017— 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: Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F. 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
Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F
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.