An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
Reason for recall: An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU). Distribution: Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM Quantity: 241,457 units Lot/code info: Product Code 004125: UDI-DI: 10614559105146, Batch Numbers: 183661 184078 183932 183978 184625 184161 185463 184714 185887 186028 185625 185757 186207 186128 186325 190281 190276 190147 190420 190618 190696 190638 191023 190751 191115 191424 191816 192724 192882 193070 193135 193211 193355 193449 193541 193390 193403 194160 194100 193579 193819 193958 194669 194613 195265 195597 194473 194777 194814 194358 194912 195044 195046 196082 186379 195736 196130 196129 196726 196624 196583 196956 197226 200458 200509 200447 200910 200973 202143 201381 201224 201431 202185 202229 202607 202268 203198 202299 203196 202315 202603 202606 203558 207076 208392 207075 202605 207834 207833 209000 202949 208391 208922 204137 210624 210429 203956 203672 210070 209144 207077 209460 210237 204299 208845 207832 207602 206689 204298 206750 209459 211798 210071 207764 207601 207600 211800 207222 206815 208921 208018 211801 208054 210025 210287 210285 210288 210510 209205 211799 210430 208053 210236 210092 210094 210093 210026 211802 208055 210072 208348 210286 208390 209255 208179 208178 SM2204025 SM2204023 SM2204019 SM2204022 SM2204024 SM2204027 SM2204021 SM2204020 SM2204026 SM2206034 SM2206038 SM2206035 SM2206039 SM2206036 SM2206037 SM2210032; Product Code 004225: UDI-DI: 10614559105153, Batch Numbers: 183863 185939 186249 186007 185713 190855 191581 191218 190452 191770 191342 193933 194392 193588 194071 196131 194203 195789 196858 200030 197301 196905 197138 200625 201515 201636 201778 208923 2
10614559105146, 10614559105153, 10614559105160, 10614559103456
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.