FDA Device Recall Z-0332-2022: Covidien Llc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0332-2022.

Recall Res Number

Z-0332-2022

Recalling Firm / Manufacturer

Covidien Llc

FEI Number

1282497

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2021-11-12

Date Posted

N/A

Date Terminated

N/A

Product Code

LFL

Event Number

89024

Product Quantity

2 units OUS

Product Description 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

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

Action Details 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

Distribution Pattern Brazil

Code Information / Serial Numbers Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896

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Medical Device Recall: Z-0332-2022

Recall Parameters & Description

Related Establishments / Registrations

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