Recall Z-0332-2022 ยท LFL Instrument, Ultrasonic Surgical
Covidien Llc
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
| Date | Nov 12, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Medtronic customer communication translated by in-country representatives emailed on November 12, 2021. Letter states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of the affected item code with the associated serial numbers listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated serial numbers must be returned. 3. If you have distributed the Covidien Sonicision" Battery Chargers listed above, please promptly forward the information from this letter to those recipients |
| Quantity | 2 units OUS |
| Distribution | Brazil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), So Covidien, LLC, Mar 26, 2018 |