FDAFDA · Alimentos y medicamentos·N.º oficial Z-1949-2012
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
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 HEP0001-US, serial numbers SPSN0808U285, PN1010U507, PN1102U092, PN1102U110, SPSN0905U022, SPSN0907U048, SPSN0909U091, SPSN0605U388, SPSN0810U506, PN1102U093, PN1102U101, PN1102U112, PN1104U199, PN1104U201, PN1104U203, PN1104U214, PN1104U215, PN1104U216, PN1104U217, PN1104U220, PN1104U224, PN1104U225, PN1106U365, SPSN0804U387, SPSN0605U421, SPSN0605U423, SPSN0605U425, SPSN0605U431, SPSN0605U432, SPSN0605U440, SPSN0605U199, SPSN0605U365, SPSN0901U033, SPSN0605U206, SPSN0605U214, SPSN0605U217, SPSN0605U220, SPSN0801U071, SPSN0801U072, SPSN0707U484, SPSN0709U689, SPSN0709U692, SPSN0709U693, SPSN0710U842, P0129686, P0123033, SPSN0808U284, P0120989, SPSN0703U140, P0116656, SPSN0605U241, SPSN0605U242, SPSN0605U243, SPSN0605U244, SPSN0605U245, SPSN0605U246, SPSN0605U247, SPSN0605U248, SPSN0605U249, SPSN0605U350, SPSN0605U351, SPSN0605U352, SPSN0605U353, SPSN0808U199, PN1009U430, PN1008U393, SPSN0904U419, SPSN0906U038, SPSN0605U138, SPSN0605U140, SPSN0605U145, SPSN0605U148, SPSN0605U153, SPSN0605U414, SPSN0605U416, SPSN0605U420, P0121743, SPNS0706U431, SPNS0706U433, SPNS0706U443, SPNS0706U445, SPSN0605U412, SPSN0605U442, SPSN0605U447, SPSN0605U451, SPSN0605U461, SPSN0605U469, SPSN0605U473, SPSN0605U480, SPSN0704U296, SPSN0704U297, SPSN0704U300, SPSN0704U301, SPSN0709U767, SPSN 907U052, SPSN0705U398, PN1101U039, P0122276, SPSN0605U355, SPSN0605U356, SPSN0605U373, SPSN0605U375, PN1104U219, SPSN0605U362, SPSN0605U189, SPSN0605U233, SPSN0605U212, SPSN0605U237, SPSN0703U123, SPSN0703U129, SPSN0707U456, SPSN0707U466, SPSN0707U467, SPSN0707U468, SPSN0707U470, SPSN0707U475, SPSN0707U480, SPSN0707U483, SPSN0707U485, SPSN0710U878, SPSN0710U882, SPSN0904U415, SPSN0907U040, SPSN0907U060, SPSN0908U031, SPSN0605U378, SPSN0810U502, SPSN0801U073, SPSN0605U226, PN1010U517, SPSN0904U437, SPSN0904U442, SPSN0904U447, SPSN0904U453, SPSN0906U004, SPSN0906U007, SPSN0906U009, SPSN0906U012, SPSN0906U013, SPSN0906U014, SPSN0906U016, SPSN0803U350, PN1101U049, PN1101U054, PN1101U056, PN1106U379, SPSN0605U407, SPSN0605U410, SPSN0605U415, SPSN0901U029, SPSN0901U030, SPSN0901U036, SPSN0901U037, SPSN0901U041, SPSNO605U178, SPSNO605U179, SPSN0703U127, P0130066, SPSN0605U134, SPSN0605U149, SPSN0605U150, SPSN0902U218, SPSN0904U423, SPSN0705U395, SPSN0901U107, SPSN0901U023, SPSN0901U039, PN1104U242, SPSN0901U050, SPSN0808U164, SPSN0907U029, SPSN0703U198, SPSNO605U167, SPSN0605U411, PN1104U247, PN1105U293, SPSN0605U210, SPSN0807U145, SPSN0808U156, SPSN0808U163, SPSN0808U165, SPSN0808U166, PN1006U301, SPSN0907U038, SPSN0605U471, SPSN0605U418, SPSN0605U208, PN1105U306, SPSN0811U602, SPSN0909U088, SPSN0702U046, SPSN0702U047, SPSN0702U048, SPSN0702U052, SPSN0702U054, SPSN0702U055, SPSN0804U390, SPSN0901U040, P0130065, SPSN0705U393, SPSN0707U473, SPSN0710U849, PN1104U252, P0120986, SPSN0810U497, PN1010U510, P0116659, SPSN0904U379, SPSN0904U380, SPSN0904U392, SPSN0904U394, SPSN0904U395, PN1010U508, SPSN0810U408, SPSN0810U419, SPSN0605U177, SPSN0808U283, SPSNO605U166, SPSN0803U343, SPNS0706U437, SPNS0706U447, SPSN0605U390, PN1008U381, SPSN0605U370, SPSN0703U125, SPSN0805U036, SPSN0805U038, SPSNO605U168, SPSNO605U181, SPSNO605U184, SPSN0605U234, SPSN0902U208, SPSN0605U401, SPSN0707U478, SPSN0605U221, PN1105U312, PN1008U382, PN1106U361, SPSN0710U844, SPSN0809U371, SPSN0808U280, SPSN0709U762, SPSN0801U064, SPSN0803U346, SPSN0904U393, SPSN0605U400, SPSN0806U075, SPSN0806U076, SPSN0806U077, SPSN0806U079, SPSN0707U481, SPSN0905U019, P0109559, P0109642, SPSN0605U474, SPSN0709U694, PO106458, SPSN0709U763, SPSN0901U112, SPSN0605U384, SPSN0810U423, SPSN0605U205, SPSN0804U377, SPSN0605U194, SPSN0904U388, SPSN0709U688, SPSN0710U883, SPSN0710U896, SPSN0810U512, SPSN0904U429, SPSN0605U462, SPSN0605U385, SPSN0605U387, SPSN0605U231, SPSN0605U235, PN1009U439, SPSN0801U132, SPSN0801U135, SPSN0801U136, SPSN0904U439, SPSN0904U443, PN1101U038, PN1102U079, PN1102U094, PN1102U105, PN1104U196, SPSN0805U037, SPSN0707U461, SPSN0605U419, PN1105U305, SPS
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.