Device product
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Z-0105-2016
Product summary
- 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
Label incorrect