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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1947-2012
Classification Class II
Code Info 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, 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GB080406587T, GB080406588T, GB080406589T, GB080406590T, GB090408369T, GB100409061T, GB100409062T, GB100409063T, GB100409064T, GB100409065T, GB110536258T, GB110536259T, GB110536260T, GB110536261T, GB110536262T, GB110538376T, GB110538377T, GB110538378T, GB110538379T, GB110538380T, GB110538381T, GB120414431T, GB120414432T, GB120414434T, GB120414435T, GB120538993T, GB120539982T, GB120539983T, GB120539984T, GB120539985T, GB120539986T, GB120539987T, GB120539988T, GB120539989T, GB120539990T, GB130415797T, GB130415798T, GB130415799T, GB130415800T, GB130542463T, GB160423254T, GB160423255T, GB160423392T, GB160423393T, GB160423394T, GB160423395T, GB160423396T, GB160423398T, GB170423901T, GB180426258T, GB180426259T, GB180426261T, GB180426263T, GB180426264T, GB180426265T, GB200430011T, GB200430012T, GB200430013T, GB200430014T, GB200430015T, GB200430017T, GB200430018T, GB200430019T, GB200430020T, GB210430841T, GB210430842T, GB220434609T, GB220434610T, GB220434611T, GB240436836T, GB240436837T, GB240436838T, GB240436839T, GB240437517T, GB240437518T, GB240438478T, GB240438479T, GB240438480T, GB270444518T, GB270444519T, GB270444520T, GB270444521T, GB280445596T, GB280446659T, GB290447966T, GB290447967T, GB290447968T, GB290447969T, GB290447970T, GB290447971T, GB290447972T, GB290447973T, GB290447974T, GB290447975T, GB290448062T, GB290448063T, GB290448064T, GB290448065T, GB290448066T, GB300448458T, GB300448459T, GB300449263T, GB300449265T, GB300449266T, GB300449267T, GB300449268T, GB300449269T, GB300449270T, GB310450735T, GB320451842T, GB320451843T, GB320451844T, GB320451847T, GB320451849T, GB330453171T, GB330453172T, GB330453173T, GB330453176T, GB340455504T, GB340455505T, GB400463858T, GB400463859T, GB400463860T, GB400463861T, GB400463862T, GB440473707T, GB440473708T, GB440473709T, GB440473710T, GB470479722T, GB470479723T, GB470479724T, GB470479726T, GB470479727T, GB470479728T, GB470479729T, GB470479730T, GB470480473T, GB470480474T, GB470480475T, GB470480477T, GB470480478T, GB470480479T, GB470480480T, GB470480481T, GB470480707T, GB470480708T, GB470480709T, GB470480710T, GB470480711T, GB470480712T, GB470480713T, GB470480714T, GB470480715T, GB480405320T, GB480405321T, GB480405322T, GB480405323T, GB480405324T, GB480480963T, GB490407629T, GB490407630T, GB490407631T, GB490407632T, GB490407633T, GB490407634T, GB490407635T, GB490407636T, GB490407637T, GB490407990T, GB490407991T, GB490407992T, GB490407993T, GB490407995T, GB490407996T, GB490407997T, GB490408366T, GB490408367T, GB490408368T, GB490408369T, GB490408370T, GB490408371T, GB490408372T, GB490408373T, GB490408374T, GB490408375T, GB490408376T, GB490408377T, GB490408378T, GB490408379T, GB490408380T, GB490408381T, GB490408382T, GB490408383T, GB490408384T, GB490408385T, GB490408386T, GB490408388T, GB490408389T, GB490408390T, GB490408391T, GB490408392T, GB490408393T, GB490408394T and GB490408395T; and Model KKB5042-21US, serial numbers 020493491301, 020493491303, 020493491304, 020493491305, 020493491306, 020493491307, 020493491308, 020493491309, 020493491310, 030288866910, 030493491401, 030493491402, 030493491403, 030493491404, 030493491406, 030493491407, 030493491409, 030493491410, 030493508001, 030493508002, 030493508003, 030493508004, 040391135105, 040391135106, 040391135107, 040391135108, 040391135109, 040391135201, 040391135202, 040391135203, 040391135205, 040391135206, 040391135207, 040391135208, 040391135209, 050391135305, 050391135306, 050391135307, 050391135308, 050391135309, 080391293604, 080391293605, 080391293606, 080391293607, 080391293608, 080391293609, 080391293610, 110289228210, 130289259601, 130289259602, 130289259603, 130289259604, 130289259605, 130289259606, 130289259607, 130289259608, 130289259610, 140391458801, 140391458802, 140391458803, 140391458804, 140391458805, 140391458806, 140391458807, 140391458808, 140391458809, 140391458810, 150289328401, 150289328402, 150289328403, 150289328404, 150289328405, 150289328406, 150289328407, 150289328408, 150289328409, 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Product Distributed Qty 2,552 units in the U.S., 4,970 units in the rest of the world
Reason For Recall 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.

Event Detail

Event Id 62116
Product Type Devices
Status Ongoing
Recalling Firm Arjo, Inc. dba ArjoHuntleigh
City Addison
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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
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