—#190299

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

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K180149
Affected lot / code info: Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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. 4. Complete the Recalled Product Return Form even if you do not have inventory. Fax to 800-895-6140 or email to rs.covidienfeedbackcustomerservice@medtronic.com Credit for returned affected product will be issued based on the RGA number. Exception: Customers with zero inventory, fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Brazil

Timeline

Recall initiated: 2021-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190299. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.