LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Summary
The FDA issued a Class II for LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 by CooperSurgical, Inc.. Reason: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requir.
Details
Source
Device Recall
External ID
Z-0260-2022
Action Date
2021-11-24
Status
Ongoing
Category
device
Product Description
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Lot/Code Info: Serial Numbers: 2018100001 2018100002 2018100003
Quantity Affected: 75 Units
Reason for Recall
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
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-0260-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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