CooperSurgical, Inc. recalls Colpo-Pneumo Occluder, Part CPO-6

Recall date

September 4, 2018

Source

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

Recall number

Z-0098-2019

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to…

Why it was recalled

The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

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

What was recalled

Colpo-Pneumo Occluder, Part CPO-6