Windstone Medical Packaging, Inc. recalls Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure

Recall date

March 16, 2017

Source

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

Recall number

Z-1798-2017

FDA classification

Class II

Brand / firm

Windstone Medical Packaging, Inc.

Sold / distributed

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

Why it was recalled

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

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

What was recalled

Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure