Class 2 Device Recall Covidien

• Date Initiated by Firm: June 23, 2021
• Create Date: August 10, 2021
• Recall Status: Completed
• Recall Number: Z-2240-2021
• Recall Event ID: 88271
• 510(K)Number: K180149
• Product Classification: Instrument, ultrasonic surgical - Product Code LFL
• Product: Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. ; Product Number: SCGAA
• Code Information: Serial Numbers: 540042X001 540042X002 540042X003 540042X004 540042X005 540042X006 540042X007 540042X008 540042X009 540042X010 540042X011 540042X012 540042X013 540042X014 540042X015 540042X016 540042X017 540042X018 540042X019 540042X020 540042X021 540042X022 540042X023 540042X024 540042X025 540042X026 540042X027 540042X028 540042X029 540042X030 540042X031 540042X032 540042X033 540042X034 540042X035 540042X036 540042X037 540042X038 540042X039 540042X040 540042X041 540042X042 540042X043 540042X044 540042X045 540042X046 540042X047 540042X048 540042X049 540042X050 540042X051 540042X052 540042X053 540042X054 540042X055 540042X056 540042X057 540042X058 540042X059 540042X060 540042X061 540042X062 540042X063 540042X064 540042X065 540042X066 540042X067 540042X068 540042X069 540042X070 540042X071 540042X072 540042X073 540042X074 540042X075 540042X076 540042X077 540042X078 540042X079 540042X080 540042X081 540042X082 540042X083 540042X084 540042X085 540042X086 540042X087 540042X088 540042X089 540042X090 540042X091 540042X092 540042X093 540042X094 540042X095 540042X097 UDI-Device Identifier (GTIN/UPN):10884521592865
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: SAME; 508-261-8000
• Manufacturer 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
• FDA Determined 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, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. We request that you contact Medtronic if you experienced a quality problem or adverse event. ¿ Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
• Quantity in Commerce: 96 units
• Distribution: US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = LFL and Original Applicant = Covidien, llc