Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
Summary
The FDA issued a Class II for Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W by CooperSurgical, Inc.. Reason: XXX.
Details
Source
Device Recall
External ID
Z-0263-2022
Action Date
2021-11-24
Status
Ongoing
Category
device
Product Description
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
Lot/Code Info: Serial Numbers: 0111001 0111003 0111004 0111005 0111006 0112001 0112002 0112003 0113001B 0113002B 0113003B 0113004B 0113005B 0113006B 0113007B 0113008B 0113010B 0114001 0114002 0114003 0114004 0114005 0114006 0114007 0114008 0114009 0114010 0209015 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0312001 0312002 0312009 0312009FIX 0312010 0312028 0413001B 0414001 0414003 0414004 0414008 0414014 0414018 0512001B 0512002B 0513001B 0513002B 0513003B 0514005 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0712001B 0712002B 0712003B 0712004B 0712005B 0712006B 0713001C 0713002C 0713003C 0713004C 0713005C 0713006C 0809001SYC 0813020C 0813021C 0813022C 0813023C 0813024C 0813025C 0814010 1012001B 1012002B 1012003B 1012004B 1012005B 1012006B 1012007B 1012008B 1012009B 1012010B 1109018 1109019 1113001C 1113002C 1113003C 1113004C 1113005C 1113006C 1113007C 1113008C 1113009C 1113010C 1213001 1213002 1213003 1214007 2015040001 2015040002 2015040003 2015040004 2015040005 2015050001 2015050002 2015060001 2015060002 2015060003 2015060004 2015060005 2015070004 2015090002 2015090003 2016050001 2016050005 2016070001 2016070002 2016070003 2016070004 2016070005 2016100001 2016100002 2016100003 2016100004 2016100005 2016100006 2016120002 2016120003 2016120004 2016120005 2016120006 2016120007 2016120008 2017060003 2017060005 QTM-AB-1-002 QTMAB-12-175
Quantity Affected: 154 Units
Reason for Recall
XXX
Distribution
US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-29
Company
Trumbull, CT
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 403 device-related FDA actions this month.
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 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 (CooperSurgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperSurgical, Inc. have FDA actions?
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0263-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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