Recall Z-2427-2018— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2018-03-15, terminated 2019-12-11. It names one FDA 510(k) clearance: K150091. Product: 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: Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-15
- Terminated
- 2019-12-11
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.