Recall Z-0332-2022— Covidien Llc

Name: FDA recall Z-0332-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-12

Class II · Ongoing

Class II FDA medical device recall by Covidien Llc, initiated 2021-11-12. It names one FDA 510(k) clearance: K180149. Product: Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA. Reason: Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit.

Recalling firm: Covidien Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-11-12
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 Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

Reason for recall

Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit

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