Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the
Summary
The FDA issued a Class II for Covidien Sonicision Reusable Generator-converts electrical power from the batter by Covidien Llc. Reason: Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause.
Details
Source
Device Recall
External ID
Z-2240-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Lot/Code Info: Serial Numbers: 540042X001 540042X002 540042X003 540042X004 540042X005 540042X006 540042X007 540042X008 540042X009 540042X010 540042X011 540042X012 540042X013 540042X014 540042X015 540042X016 540042X017 540042X018 540042X019 540042X020 540042X021 540042X022 540042X023 540042X024 540042X025 540042X026 540042X027 540042X028 540042X029 540042X030 540042X031 540042X032 540042X033 540042X034 540042X035 540042X036 540042X037 540042X038 540042X039 540042X040 540042X041 540042X042 540042X043 540042X044 540042X045 540042X046 540042X047 540042X048 540042X049 540042X050 540042X051 540042X052 540042X053 540042X054 540042X055 540042X056 540042X057 540042X058 540042X059 540042X060 540042X061 540042X062 540042X063 540042X064 540042X065 540042X066 540042X067 540042X068 540042X069 540042X070 540042X071 540042X072 540042X073 540042X074 540042X075 540042X076 540042X077 540042X078 540042X079 540042X080 540042X081 540042X082 540042X083 540042X084 540042X085 540042X086 540042X087 540042X088 540042X089 540042X090 540042X091 540042X092 540042X093 540042X094 540042X095 540042X097 UDI-Device Identifier (GTIN/UPN):10884521592865
Quantity Affected: 96 units
Reason for Recall
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
Distribution
US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-23
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 183 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-2240-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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