FDA recall Z-0263-2022

CooperSurgical, Inc. · Class II · device

Product

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W

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

Key facts

Status: Ongoing
Initiation date: 2021-09-29
Report date: 2021-11-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0263-2022