Recall Z-0145-2017— Windstone Medical Packaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2015-04-22, terminated 2016-10-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room. Reason: 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..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-22
- Terminated
- 2016-10-25
- Firm location
- Billings, MT, United States
Product description
Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.