FDA-Device2018-10-17Class II
Colpo-Pneumo Occluder, Part CPO-6
CooperSurgical, Inc.
Hazard
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Sold states
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 the following foreign countries: Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.
Affected count
32538
Manufactured in
95 Corporate Dr, Trumbull, CT, United States
Products
Colpo-Pneumo Occluder, Part CPO-6
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0098-2019Don't want to check this manually?
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