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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Sonicision Battery Charger

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 Class 2 Device Recall Covidien Sonicision Battery Chargersee related information
Date Initiated by FirmNovember 12, 2021
Create DateDecember 03, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0332-2022
Recall Event ID 89024
510(K)NumberK180149 
Product Classification Instrument, ultrasonic surgical - Product Code LFL
ProductCovidien 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
Code Information Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896
FEI Number 1282497
Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information ContactSAME
508-261-8000
Manufacturer 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 2		Under Investigation by firm
ActionMedtronic 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
Quantity in Commerce2 units OUS
DistributionBrazil
Total Product Life CycleTPLC 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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LFL
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