Recall Z-2240-2021 ยท LFL Instrument, Ultrasonic Surgical
Covidien Llc
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
| Date | Jun 23, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Covidien notified consignees by Urgent Medical Device Recall letter delivered via Federal Express and/or certified mail beginning June 23, 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 associated lot and serial numbers listed on Attachment A. 2. Please return affected product as indicated below. All products from the affected item code and associated lot and serial numbers must be returned. 3. If you have distributed the Covidien Sonicision" Reusable Generators listed on Attachment A, p |
| Quantity | 96 units |
| Distribution | US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA. |
| 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 |