CooperSurgical, Inc. recalls CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

Recall date

April 9, 2020

Source

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

Recall number

Z-2112-2020

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI

Why it was recalled

The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

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

What was recalled

CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21