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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1947-2012

Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

Publicado el 18 de julio de 2012 · Inicio del retiro: 29 de junio de 2012

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

ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Arjo, Inc. dba ArjoHuntleigh
Distribuidor
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey
Lote
Models KKB5022-21US, serial numbers 010390894401, 010390894402, 010390894403, 010390894405, 010390894408, 010390894410, 020390958503, 030186208608, 030186208609, 030186208610, 030186208701, 030186208702, 030186208704, 030186208705, 030186208706, 030186208707, 030186208708, 030186208709, 030186208710, 030186208801, 030186208802, 030186208803, 030186208804, 030186208810, 030186208903, 040186294405, 040186453504, 040186453507, 040186453508, 040186453509, 040391134003, 040391134004, 040391134005, 040391134006, 040391134007, 040391134008, 040391134009, 050186453403, 050186453404, 050186453405, 050186453406, 050186453407, 050186453408, 050186453409, 050186453410, 050186453601, 050186453602, 050186453603, 050186453604, 050186453605, 050186453606, 050186453607, 050186453608, 050186453609, 050186453610, 050288869704, 050288869705, 050288869706, 050288869707, 050288869708, 050288869709, 050288869710, 050288888001, 050288888002, 050288888003, 050288888004, 050288888005, 050288888006, 050288888007, 050288888008, 050288888009, 050288888010, 050288913901, 050288913902, 050288913903, 050288913909, 050288913910, 050288914001, 050288914002, 050288914003, 050288914004, 050288914005, 050288914006, 050288914007, 050288914008, 050288914009, 050288914010, 060186453701, 060186453702, 060186453703, 060186453704, 060186453705, 060186453706, 060186453708, 060186453709, 060186453710, 060186453801, 060186453802, 060186453803, 060186453804, 060186453805, 060186453806, 060288914101, 060288914102, 060288914103, 060288914104, 060288914105, 060288914106, 060288914107, 060288914108, 060288935308, 060288935309, 060288935310, 060391216706, 060391216707, 060391216708, 060391250501, 060391250502, 060391250503, 070186467909, 070186467910, 070186468001, 070186468002, 070186468003, 070186468004, 070186468005, 070186468010, 070186468105, 070186468106, 070186468201, 070288935401, 070288935402, 070288935403, 070288935404, 070288935405, 070288935406, 070288935407, 070288935408, 070288935409, 070288935410, 070288935501, 070288935502, 070288935503, 070288935504, 070288935505, 070288935506, 070288935507, 070288935508, 070288935509, 070288935510, 070288964901, 070288964902, 070288964903, 070288964904, 070288964906, 070288964908, 070288964910, 070288965003, 070288965004, 070288965005, 070288965006, 070288965007, 070288965009, 070288965010, 070288965101, 070288965102, 070288965103, 070288965104, 070288965105, 070288965106, 070288965107, 070288965108, 070288965109, 070288965110, 070288965201, 070288965202, 070288965203, 070288965204, 070288965205, 070288965206, 070288965207, 070288965208, 070288965209, 070288965210, 070288965302, 070288965303, 070288965304, 070288965305, 070288965306, 070288965307, 070288965308, 070288965309, 070288965310, 070289965301, 080186539604, 080186539605, 080186539606, 080186539607, 080186539608, 080186539609, 080186539610, 080288978501, 080288978502, 080288978503, 080288978504, 080288978505, 080288978506, 080288978507, 080288978508, 080288978509, 080288978510, 080289003801, 080289003802, 080289003803, 080289003907, 080289003908, 080289003909, 080289003910, 090084195307, 090084195310, 090084195401, 090084195404, 090084195405, 090084195406, 090084195407, 090084195408, 090084195409, 090084195410, 090186539700, 090186540003, 090186540005, 090186540006, 090186540007, 090186540008, 090186540009, 090186540010, 090289004001, 090289004002, 090289004003, 090289004004, 090289004005, 090289004006, 090289004007, 090289004008, 090289004009, 090289004010, 090289004101, 090289004102, 090289004103, 090289004104, 090289004105, 090289004106, 090289004107, 090289004108, 090289004109, 090289004110, 090289004201, 090289004202, 090289004203, 090289004204, 090289004205, 090289004206, 090289004207, 090289004208, 090289004209, 090289004210, 090289019401, 090289019402, 090289019403, 090289019404, 090289019405, 090289019406, 090289019501, 090289019502, 090289019503, 090289019505, 090289019506, 090289019507, 090289019508, 090289019509,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States