Recall Z-1339-2017— Windstone Medical Packaging, Inc.

Name: FDA recall Z-1339-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-11

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: Major Laparotomy Pack - NS, part number AMS4347. 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

Major Laparotomy Pack - NS, part number AMS4347

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.