Z-2427-2018 Class II Terminated
FDA device recall Z-2427-2018 was initiated by Covidien LLC on Mar 15, 2018 and is designated Class II. Reason for recall: Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices. The recall status is terminated (terminated Dec 11, 2019). Affected quantity: 936.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 18, 2018
- Initiation Date
- Mar 15, 2018
- Termination Date
- Dec 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 936
Product Description
LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
Reason for Recall
Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
Distribution Pattern
Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom
Code Information
Lot #s 72550127X 72770140X 72770141X 73000048X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2427-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026