CooperSurgical, Inc. Recall 88648
Description: LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
CooperSurgical, Inc. Recall 88648 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0258-2022 |
| Event ID | 88648 |
| Event Description | LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220 |
| Product Type | Devices |
| 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 |
| Quantity | 75 Units |
| Recall 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 requiring medical intervention to control any intraoperative bleeding and complete the case. |
| Device Classification | 20211124 |
| Device Code Info | Serial Numbers: 2017040001 2017040002 2017040003 2017040004 2017040005 2018030001 2018030002 2018030003 2018030004 2018100004 2018100005 2018100006 2018120001 2018120002 2018120003 2019010001 2019010002 2019010003 2019010004 2019010005 2019030001 2019030002 2019030003 2019030004 2019070001 2019070002 2019070003 2019070004 2019070005 2019070006 2019100001 2019100004 2019100005 2019120001 2019120002 2019120003 2019120004 2019120005 2019120006 2020030001 2020030002 2020030003 2020030004 2020030005 2020060001 2020060002 2020060003 2020060004 2020060005 2020060006 2020080001 2020080002 2020080003 2020080004 2020080005 2020080006 2020110001 2020110002 2020110003 2020110004 2020110005 2020110006 2020120001 2020120002 2020120003 2020120004 2020120005 2020120006 2021010001 2021010002 2021010003 2021010004 2021010005 |
| Center Classification Date | 20211118 |
| Recall Initiation Date | 20210929 |
| Recalling Firm | CooperSurgical, Inc. |
| Initial Notification | Letter |
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