FDA-Device2020-06-03Class II
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Hazard
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Sold states
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
Affected count
1740 units/174 boxes
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2112-2020Don't want to check this manually?
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