Recall Z-0220-2017— Windstone Medical Packaging, Inc.

Name: FDA recall Z-0220-2017
Creator: U.S. Food and Drug Administration
Published: 2015-04-22

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: Laparoscopy Pack, Kit number AMS2537 and AMS2537(A 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

Laparoscopy Pack, Kit number AMS2537 and AMS2537(A 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.