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CooperSurgical, Inc. recalls CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Recalled June 3, 2020 · FDA recall Z-2112-2020 · CooperSurgical
Hazard
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. · FDA Class II
Units
1740 units/174 boxes
Sold at
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
Description
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Product
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →