FDA-Device2020-06-03Class II
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
CooperSurgical, Inc.
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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