Windstone Medical Packaging, Inc. recalls Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity…

Recall date

January 11, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1295-2017

FDA classification

Class II

Brand / firm

Windstone Medical Packaging, Inc.

Sold / distributed

Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A