CooperSurgical, Inc. recalls MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

Recall date

May 20, 2015

Source

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

Recall number

Z-1814-2015

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND

Why it was recalled

A diaphragm size 80 labeled box was incorrectly packaged with a size 85.

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

What was recalled

MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80