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CooperSurgical, Inc. recalls Colpo-Pneumo Occluder, Part CPO-6
Recalled October 17, 2018 · FDA recall Z-0098-2019 · CooperSurgical
Hazard
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. · FDA Class II
Units
32538
Sold at
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.
Description
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Product
Colpo-Pneumo Occluder, Part CPO-6
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →