FDA-Device2015-10-14Class III
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
CooperSurgical, Inc.
Hazard
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
Sold states
US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.
Affected count
305 units
Manufactured in
75 Corporate Dr, N/A, Trumbull, CT, United States
Products
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2016Don't want to check this manually?
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