FDAFDA · Alimentos y medicamentos·N.º oficial Z-1759-2017
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
Publicado el 19 de abril de 2017 · Inicio del retiro: 28 de febrero de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- ConMed Corporation
- Distribuidor
- Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
- Lote
- Serial Numbers: 1640179, 15500473, 16090084, 16140185, 16170283, 16250376, 16370476, 16380489, 1640180, 15510474, 16090085, 16140186, 16170284, 16250377, 16370477, 16380490, 1640181, 15510475, 16090086, 16140187, 16170285, 16250378, 16370478, 16380491, 1640182, 15510476, 16090087, 16140188, 16170286, 16260379, 16380479, 16380492, 1640183, 15510477, 16090088, 16140189, 16170287, 16260380, 16380480, 16480592, 1640184, 15510478, 16090089, 16140190, 16170288, 16260381, 16380481, 16480593, 1640185, 15510479, 16090090, 16140191, 16170289, 16260382, 16380482, 16480594, 1640186, 15510480, 16090091, 16140192, 16170290, 16260383, 16380483, 16480595, 1640187, 15510481, 16090092, 16140193, 16170291, 16260384, 16380484, 16480596, 1640188, 15510482, 16090093, 16140194, 16170292, 16260385, 16380485, 16480597, 15260015, 15510483, 16090094, 16140195, 16170293, 16260386, 16380486, 16480598, 15260016, 15510484, 16090095, 16140196, 16170294, 16260387, 16380487, 16480599, 15260018, 15510485, 16090096, 16140197, 16170295, 16260388, 16380488, 16500600, 15260020, 15510486, 16090097, 16140198, 16170296, 16260389, 16380493, 16500601, 15260022, 15510487, 16090098, 16150199, 16170297, 16260390, 16430494, 16500602, 15260023, 15510488, 16090099, 16150201, 16170298, 16260391, 16430495, 16500603, 15280038, 15510489, 16090100, 16150202, 16190299, 16260392, 16430496, 16500604, 15280044, 15510490, 16090101, 16150203, 16190300, 16260393, 16430497, 16500605, 15280046, 15510491, 16090102, 16150203, 16190301, 16260394, 16430499, 16500606, 15280048, 15510492, 16090103, 16150204, 16190302, 16260395, 16430500, 16500607, 15280049, 15510493, 16090104, 16150205, 16190303, 16260396, 16430501, 16500608, 15280052, 16010001, 16090105, 16150206, 16190304, 16260397, 16430502, 16500609, 15280053, 16010002, 16090106, 16150207, 16190305, 16260398, 16430503, 16500610, 15280054, 16010003, 16090107, 16150208, 16190306, 16260399, 16430504, 16500611, 15280055, 16010004, 16090108, 16150209, 16190307, 16260400, 16430505, 16500612, 15280056, 16010005, 16090109, 16150210, 16190308, 16260401, 16430506, 16500613, 15280060, 16010006, 16090110, 16150211, 16190309, 16260402, 16430507, 16500614, 15280061, 16010007, 16090111, 16150212, 16190310, 16260403, 16430508, 16500615, 15280062, 16010008, 16090112, 16150213, 16190311, 16260404, 16430509, 16500616, 15280063, 16010009, 16090113, 16150214, 16190312, 16260405, 16430510, 16500617, 15330199, 16010010, 16090114, 16150215, 16190313, 16260406, 16430511, 16500618, 15330200, 16010011, 16090115, 16150216, 16190314, 16260407, 16430512, 16500619, 15330201, 16010012, 16090116, 16150217, 16190315, 16260408, 16430513, 16500637, 15330202, 16010013, 16090117, 16150218, 16190316, 16350409, 16440524, 16510620, 15330203, 16020014, 16090118, 16150219, 16190317, 16350410, 16440525, 16510621, 15340206, 16020015, 16090119, 16150220, 16190318, 16350411, 16440526, 16510622, 15340207, 16020016, 16090120, 16150221, 16210319, 16350412, 16440527, 16510623, 15340208, 16020017, 16090121, 16150222, 16210320, 16350413, 16440528, 16510624, 15340209, 16020018, 16090122, 16150223, 16210321, 16350414, 16440529, 16510626, 15340211, 16020019, 16090123, 16150224, 16210322, 16350415, 16440530, 16510627, 15340212, 16020020, 16110124, 16150225, 16210323, 16350416, 16440531, 16510628, 15340213, 16020021, 16110125, 16150226, 16210324, 16350417, 16440532, 16510630, 15340214, 16020022, 16110126, 16150227, 16210325, 16350418, 16440533, 16510631, 15340215, 16020023, 16110127, 16150228, 16210326, 16350419, 16440534, 16510632, 15340216, 16020024, 16110128, 16150229, 16210327, 16350420, 16440535, 16510633, 15340217, 16020025, 16110129, 16150230, 16210328, 16350421, 16440536, 16510634, 15340218, 16020026, 16110130, 16150231, 16210329, 16350422, 16440537, 16510635, 15340219, 16020027, 16110131, 16150232, 16210330, 16350423, 16440538, 16510638, 15340220, 16020028, 16110132, 16150233, 16210331, 16350424, 16460539, 16510639, 15340221, 16020029, 16110133, 16160234, 16210332, 16350425, 16460540, 16
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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