CooperSurgical, Inc. recalls CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

Recall date

September 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0105-2016

FDA classification

Class III

Brand / firm

CooperSurgical, Inc.

Sold / distributed

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.

Why it was recalled

Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061