Recall Z-0218-2017— Windstone Medical Packaging, Inc.

Name: FDA recall Z-0218-2017
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: Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(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

Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(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.