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Recall Observatory FDA recall evidence

Device product

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

Z-0105-2016

September 01, 2015

Class III

Product summary

Firm
CooperSurgical, Inc.
Event
Event 72107
Status
Terminated
Classification
Class III
Quantity
305 units
Official record key
device-enforcement:Z-0105-2016

Official wording

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

Code information: LOT 187889

Distribution pattern: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Label incorrect