Z-1840-2019 Class II Terminated
FDA device recall Z-1840-2019 was initiated by CooperSurgical, Inc. on April 23, 2019 and is designated Class II. Reason for recall: 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses. The recall status is terminated (terminated April 24, 2020). Affected quantity: 19.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- April 23, 2019
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19
Product Description
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .
Reason for Recall
2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
Distribution Pattern
US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI.
Code Information
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