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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2156-2014

Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.

Publicado el 13 de agosto de 2014 · Inicio del retiro: 24 de junio de 2014

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

The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Stryker Instruments Div. of Stryker Corporation
Distribuidor
Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI & WV.
Lote
Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s: 01H0001 04G0251 06C0499 07G0748 08L1000 1018200054 1106200054 1202400194 1231200284 1320000054 01H0002 04G0252 06C0500 07G0749 08L1001 1018200064 1106200074 1202400204 1231200294 1320000064 01H0003 04G0253 06C0501 07G0750 08L1002 1018200074 1106200084 1202400214 1231200304 1320000074 01H0004 04G0254 06C0502 07G0751 08L1003 1018200084 1106700014 1202400224 1231200314 1320000084 01H0005 04G0255 06C0503 07G0752 08L1004 1018200094 1106700024 1202400234 1231200324 1320000094 01H0006 04G0256 06C0504 07G0753 08L1005 1018200104 1106800014 1202400244 1232000014 1320000104 01H0007 04G0257 06C0505 07G0754 08L1006 1018900014 1106800024 1203200214 1232000024 1320600014 01H0008 04G0258 06C0506 07G0755 09A1007 1018900024 1106800034 1203200224 1232000034 1320600024 01H0009 04G0263 06C0507 07G0756 09A1008 1018900034 1106800044 1203200234 1232000044 1320600034 01H0010 04G0264 06C0508 07G0757 09A1009 1018900044 1106800054 1203200244 1232000064 1320600044 01I0011 04H0259 06D0509 07G0758 09A1010 1018900054 1106800064 1203200254 1232000074 1320600054 01I0012 04H0260 06D0510 07G0759 09A1011 1018900064 1106800074 1203200274 1232000084 1320600064 01I0013 04H0261 06D0511 07G0760 09A1012 1018900074 1106800084 1203700954 1232600034 1321200214 01I0014 04H0265 06D0512 07G0761 09A1013 1018900084 1106800094 1203700964 1233400044 1321200224 01I0015 04H0266 06D0513 07H0762 09A1014 1018900094 1106800104 1203700974 1233400054 1321200234 01J0016 04H0267 06D0514 07H0763 09A1015 1018900104 1108100014 1203900024 1233400064 1321200244 01J0017 04H0268 06D0515 07H0764 09A1016 1019700014 1108100024 1204000044 1233900114 1321200254 01J0018 04H0269 06D0516 07H0765 09A1017 1019700024 1108100034 1204000054 1233900124 1321200264 01J0019 04H0270 06D0517 07H0766 09A1018 1019700034 1108100044 1204800264 1234000014 1321200274 01J0020 04I0262 06D0518 07H0767 09A1020 1019700044 1108100054 1205100514 1234000024 1321200284 01J0021 04I0271 06D0519 07H0768 09A1021 1019700054 1108100064 1205100524 1234000034 1321200294 01J0022 04I0272 06D0520 07H0769 09A1022 1020200104 1108100074 1205100534 1234000044 1321200304 01J0023 04I0273 06D0521 07H0770 09A1023 1020200114 1108100084 1205100544 1234000054 1321800744 01J0024 04I0274 06D0522 07H0771 09B1024 1020200124 1108400014 1205100554 1234000064 1321800754 01J0025 04I0275 06D0523 07H0772 09B1025 1020200134 1108400024 1205100564 1234000074 1321800764 01K0026 04I0276 06E0524 07H0773 09B1026 1020200144 1108400034 1205100574 1234000084 1321800774 01K0027 04I0277 06E0525 07H0774 09B1027 1020200154 1108400044 1205100584 1234800104 1321800784 01K0028 04I0278 06E0526 07H0775 09B1028 1020200164 1108400054 1205100594 1234800114 1321800794 01K0029 04I0279 06E0527 07I0776 09B1029 1020200174 1108400064 1205100604 1234800124 1322100374 01K0030 04I0280 06E0528 07I0777 09B1030 1020200184 1108400074 1205800064 1234800134 1322100384 01L0031 04I0281 06E0529 07I0778 09B1031 1020200194 1108400084 1205800074 1234800144 1322100394 01L0032 04I0282 06E0530 07I0779 09B1032 1021100014 1108400094 1205800084 1234800154 1322100404 01L0033 04J0283 06E0531 07I0780 09B1033 1021100024 1108400104 1205800094 1235401004 1322400484 01L0034 04J0284 06E0532 07I0781 09B1034 1021100034 1109500014 1205800104 1235600014 1322400494 01L0035 04J0285 06E0533 07I0782 09B1035 1021100044 1109500024 1206200574 1235600094 1322400504 01L0036 04J0286 06E0534 07I0783 09B1036 1021800764 1109500034 1206200584 1235600104 1322400514 02A0038 04J0287 06E0535 07I0784 09B1037 1021800774 1109500044 1206200594 1235600114 1322400524 02A0039 04J0288 06E0536 07I0785 09B1038 1021800784 1109500054 1206500014 1235600124 1322400534 02A0040 04J0289 06E0537 07I0786 09C1039 1021800794 1109500064 1206500024 1235600134 1323300144 02A0041 04J0290 06E0538 07I0787 09C1040 1021800804 1109500074 1206500034 1235600144 1323800014 02A0042 04K0291 06E0539 07I0788 09C1041 1022500014 1109500084 1206800484 1300900014 13
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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