Recall Z-2240-2021— Covidien Llc

Name: FDA recall Z-2240-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-23

Class II · Terminated

Class II FDA medical device recall by Covidien Llc, initiated 2021-06-23, terminated 2025-01-28. It names one FDA 510(k) clearance: K180149. Product: Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA. Reason: Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located.

Recalling firm: Covidien Llc
Classification: Class II
Status: Terminated
Initiated: 2021-06-23
Terminated: 2025-01-28
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K180149 — Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion GuideCovidien, LLC·cleared 2018-03-26

K-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

Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA

Reason for recall

Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located

Data sourced from openFDA. This site is unofficial and independent of the FDA.