Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information o
Summary
The FDA issued a Class II for Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable B by Covidien Llc. Reason: Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Ear.
Details
Source
Device Recall
External ID
Z-0332-2022
Action Date
2021-12-15
Status
Ongoing
Category
device
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
Lot/Code Info: Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896
Quantity Affected: 2 units OUS
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
Distribution
Brazil
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-12
Company
Mansfield, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien Llc have FDA actions?
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0332-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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