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FDAFDA · Food and drugs·Recall number 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.

Published July 18, 2012 · Recall initiated: June 29, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Arjo, Inc. dba ArjoHuntleigh
Distributor
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
Lot
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,
Risk classification
Class II
Area (FDA)
device
Country
United States

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