Recall Z-0332-2022
Covidien Llc · initiated November 12, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896
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
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0332-2022
- Initiated
- November 12, 2021
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Quantity
- 2 units OUS
- Distribution
- Brazil
- Recalling firm
- Covidien Llc, Mansfield, MA