Z-0105-2016 Class III Terminated
FDA device recall Z-0105-2016 was initiated by CooperSurgical, Inc. on Sep 1, 2015 and is designated Class III. Reason for recall: Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%) The recall status is terminated (terminated Jan 29, 2016). Affected quantity: 305 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2015
- Initiation Date
- Sep 1, 2015
- Termination Date
- Jan 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305 units
Product Description
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Reason for Recall
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
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.
Code Information
LOT 187889
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0105-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026