SKU 348709 404, SKU348709 605

Physical Medicine Devices

1

No

Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, LA, MD, MI, MO, MT, NE, NV,NH, NM, NY, NC, OH,OK, and PA.

Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. || This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.

The devices in US distribution were manufactured between 29 September 2014 and 19 September 2015. Material Serialnumber 1C66=L22-2-P/0 201516011 1C66=L23-1-P/0 201525027 1C66=L23-2-P/0 201516014 201516016 201525022 1C66=L24-1-P/0 201516006 201516019 201525007 1C66=L24-2-P/0 201516002 201525012 201525020 1C66=L25-1-P/0 201449025 201518040 1C66=L25-2-P/0 201448015 201448019 201449020 201449034 201507001 201507005 201523037 1C66=L25-3-P/0 201448018 201449039 201507007 201507008 201507017 201514033 201518007 201528008 1C66=L26-1-P/0 201507006 1C66=L26-2-P/0 201444038 201444039 201444043 201444046 201444048 201449038 201507009 201507015 201507019 201528021 201528025 1C66=L26-3-P/0 201444004 201444014 201444037 201444040 201444047 201444049 201449001 201449004 201504007 201504011 201504020 201518026 1C66=L26-3-P/0 201518027 201518029 201518030 201518031 201523011 201523018 201523028 201523035 201523043 201523045 201523048 201529003 201529009 201529010 201529014 201529027 201529028 1C66=L27-2-P/0 201448012 201448020 201449008 201449013 201449027 201449030 201523027 1C66=L27-3-P/0 201444003 201444007 201444024 201444031 201444032 201444035 201444036 201444044 201449017 201449019 201449024 201449032 201449033 201504016 201504018 201504019 201504021 201504028 201518001 201518010 201518011 201518022 201518041 201523020 201528001 201528004 201528013 201528019 201528023 201529005 201529008 201529013 1C66=L27-3-P/0 201529015 201529017 201538031 1C66=L28-2-P/0 201507026 1C66=L28-3-P/0 201448022 201448023 201448027 201449037 201507027 201507028 201507029 201507030 201529040 201538014 1C66=L29-2-P/0 201507021 1C66=L29-3-P/0 201448007 201448008 201514001 201518013 201518024 201528007 201528022 201529023 201529024 1C66=R22-1-P/0 201516013 1C66=R23-1-P/0 201508008 201508020 201525039 1C66=R23-2-P/0 201508009 201508012 1C66=R24-2-P/0 201508016 201525026 1C66=R25-1-P/0 201448001 201507024 201507025 201518042 201523047 201528010 201528014 201529018 201529033 1C66=R25-2-P/0 201448006 201448009 201504004 201507032 201518016 201518043 1C66=R25-3-P/0 201448003 201448004 201448005 201504003 201504015 201504024 201514011 201514038 201518021 1C66=R25-3-P/0 201518036 201518049 201523013 201523032 201523034 1C66=R26-1-P/0 201448002 201504006 1C66=R26-2-P/0 201444002 201444008 201444025 201444028 201504009 201504013 201504026 201504027 201507016 201507023 201523024 1C66=R26-3-P/0 201448042 201448043 201448045 201448050 201504012 201504017 201504022 201504023 201504030 201507013 201507014 201507020 201518002 201518018 201518047 201523004 201523010 201523014 201523016 201523025 201523030 201523049 201523050 201529031 201529039 201538024 201538033 201538034 1C66=R27-2-P/0 201448033 201448035 201448036 201448040 201449023 201504014 201518014 201518032 201518045 201518050 1C66=R27-2-P/0 201523031 201529034 1C66=R27-3-P/0 201444010 201444015 201444016 201444017 201444023 201444027 201444029 201444034 201449005 201449009 201449021 201449026 201449031 201449035 201449040 201518017 201518023 201523003 201523005 201523006 201523017 201523026 201523033 201529019 201529045 1C66=R28-2-P/0 201507033 201510019 201518033 201523040 201529032 1C66=R28-3-P/0 201448029 201448034 201448039 201449002 201449010 201449014 201449022 201449036 201518009 201518039 201529020 1C66=R29-2-P/0 201507018 1C66=R29-3-P/0 201448041 201507010 201514002 201514020 201518037 201523038 201528009 201529002 201529026

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden.

iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

Model F00055-055 Standard Thermophore Lot codes:  0552712, 0552812, 0552912, 0553012, 0553112, 0553212, 0553312, 0553412, 0553512 , 0553612, 0553712, 0553812, 0553912, 0554012, 0554112, 0554212, 0554312, 0554412, 0554512, 0554612, 0554712, 0554812, 0554912, 0555012, 0555112, 0555212, 0550112, 0550213, 0550313, 0550413, 0550513, 0550613, 0550713, 0550813, 0550913, 0551013, 0551113, 0551213, 0551313, 0551413, 0551513, 0551613, 0551713, 0551813, 0551913, 0552013, 0552113, 0552213, 0552313, 0552413, 0552513, 0552613, 0552713, 0552813, 0552913, 0553013, 0553113, 0553213, 0553313, 0553413, 0553513, 0553613, 0553713, 0553813, 0553913, 0554013, 0554113, 0554213, 0554313, 0554413, 0554513, 0554613, 0554713, 0554813, 0554913, 055013, 0555113, 0555213, 0550113, 0550214, 0550314, 0550414, 0550514, 0550614, 0550714, 0550814, 0550914, 0551014, 0551114   Model F00255-255 Standard Thermophore Plus Lot codes: 2552712, 2552812, 2552912, 2553012, 2553112, 2553212, 2553312, 2553412, 2553512, 2553612, 2553712, 2553812, 2553912, 2554012, 2554112, 2554212, 2554312, 2554412, 2554512, 2554612, 2554712, 2554812, 2554912, 2555012, 2555112, 2555212, 2550112, 2550213, 2550313, 2550413, 2550513, 2550613, 2550713, 2550813, 2550913, 2551013, 2551113, 2551213, 2551313, 2551413, 2551513, 2551613, 2551713, 2551813, 2551913, 2552013, 2552113, 2552213, 2552313, 2552413, 2552513, 2552613, 2552713, 2552813, 2552913, 2553013, 2553113, 2553213, 2553313, 2553413, 2553513, 2553613, 2553713, 2553813, 2553913, 2554013, 2554113, 2554213, 2554313, 2554413, 2554513, 2554613, 2554713, 2554813, 2554913, 2555013, 2555113, 2555213, 2550113, 2550214, 2550314, 2550414, 2550514, 2550614, 2550714, 2550814, 2550914, 2551014, 2551114  Model F80095-095 Standard CSA Thermophore Lot code: 0952712, 0952812, 0952912, 0953012, 0953112, 0953212, 0953312, 0953412, 0953512, 0953612, 0953712, 0953812, 0953912, 0954012, 0954112, 0954212, 0954312, 0954412, 0954512, 0954612, 0954712, 0954812, 0954912, 0955012, 0955112, 0955212, 0950112, 0950213, 0950313, 0950413, 0950513, 0950613, 0950713, 0950813, 0950913, 0951013, 0951113, 0951213, 0951313, 0951413, 0951513, 0951613, 0951713, 0951813, 0951913, 0952013, 0952113, 0952213, 0952313, 0952413, 0952513, 0952613, 0952713, 0952813, 0952913, 0953013, 0953113, 0953213, 0953313, 0953413, 0953513, 0953613, 0953713, 0953813, 0953913, 0954013, 0954113, 0954213, 0954313, 0954413, 0954513, 0954613, 0954713, 0954813, 0954913, 0955013, 0955113, 0955213, 0950113, 0950214, 0950314, 0950414, 0950514, 0950614, 0950714, 0950814, 0950914, 0951014, 0951114    Model F00077-077 Petite Thermophore Lot codes:  0772712, 0772812, 0772912, 0773012, 0773112, 0773212, 0773312, 0773412, 0773512, 0773612, 0773712, 0773812, 0773912, 0774012, 0774112, 0774212, 0774312, 0774412, 0774512, 0774612, 0774712, 0774812, 0774912, 0775012, 0775112, 0775212, 0770112, 0770213, 0770313, 0770413, 0770513, 0770613, 0770713, 0770813, 0770913, 0771013, 0771113, 0771213, 0771313, 0771413, 0771513, 0771613, 0771713, 0771813, 0771913, 0772013, 0772113, 0772213, 0772313, 0772413, 0772513, 0772613, 0772713, 0772813, 0772913, 0773013, 0773113, 0773213, 0773313, 0773413, 0773513, 0773613, 0773713, 0773813, 0773913, 0774013, 0774113, 0774213, 0774313, 0774413, 0774513, 0774613, 0774713, 0774813, 0774913, 0775013, 0775113, 0775213, 0770113, 0770214, 0770314, 0770414, 0770514, 0770614, 0770714, 0770814, 0770914, 0771014, 0771114, 0771214, 0771314, 0771414, 0771514, 0771614, 0771714, 0771814, 0771914, 0772014, 0772114, 0772214, 0772314, 0772414, 0772514, 0772614, 0772714  Model F00277-277 Petite Thermophore Plus lot codes: 2772712, 2772812, 2772912, 2773012, 2773112, 2773212, 2773312, 2773412, 2773512, 2773612, 2773712, 2773812, 2773912, 2774012, 2774112, 2774212, 2774312, 2774412, 2774512, 2774612, 2774712, 2774812, 2774912, 2775012, 2775112, 2775212, 2770112, 2770213, 2770313, 2770413, 2770513, 2770613, 2770713, 2770813, 2770913, 2771013, 2771113, 2771213, 2771313, 2771413, 2771513, 2771613, 2771713, 2771813, 2771913, 2772013, 2772113, 2772213, 2772313, 2772413, 2772513, 2772613, 2772713, 2772813, 2772913, 2773013, 2773113, 2773213, 2773313, 2773413, 2773513, 2773613, 2773713, 2773813, 2773913, 2774013, 2774113, 2774213, 2774313, 2774413, 2774513, 2774613, 2774713, 2774813, 2774913, 2775013, 2775113, 2775213, 2770113, 2770214, 2770314, 2770414, 2770514, 2770614, 2770714, 2770814, 2770914, 2771014, 2771114, 2771214, 2771314, 2771414, 2771514, 2771614, 2771714, 2771814, 2771914, 2772014, 2772114, 2772214, 2772314, 2772414, 2772514, 2772614, 2772714   Model F80097-097 Petite CSA Thermophore Lot codes: 0972712, 0972812, 0972912, 0973012, 0973112, 0973212, 0973312, 0973412, 0973512, 0973612, 0973712, 0973812, 0973912, 0974012, 0974112, 0974212, 0974312, 0974412, 0974512, 0974612, 0974712, 0974812, 0974912, 0975012, 0975112, 0975212, 0970112, 0970213, 0970313, 0970413, 0970513, 0970613, 0970713, 0970813, 0970913, 0971013, 0971113, 0971213, 0971313, 0971413, 0971513, 0971613, 0971713, 0971813, 0971913, 0972013, 0972113, 0972213, 0972313, 0972413, 0972513, 0972613, 0972713, 0972813, 0972913, 0973013, 0973113, 0973213, 0973313, 0973413, 0973513, 0973613, 0973713, 0973813, 0973913, 0974013, 0974113, 0974213, 0974313, 0974413, 0974513, 0974613, 0974713, 0974813, 0974913, 0975013, 0975113, 0975213, 0970113, 0970214, 0970314, 0970414, 0970514, 0970614, 0970714, 0970814, 0970914, 0971014, 0971114, 0971214, 0971314, 0971414, 0971514, 0971614, 0971714, 0971814, 0971914, 0972014, 0972114, 0972214, 0972314, 0972414, 0972514, 0972614, 0972714   Model F00056-056 Medium Thermophore Lot codes: 0562712, 0562812, 0562912, 0563012, 0563112, 0563212, 0563312, 0563412, 0563512, 0563612, 0563712, 0563812, 0563912, 0564012, 0564112, 0564212, 0564312, 0564412, 0564512, 0564612, 0564712, 0564812, 0564912, 0565012, 0565112, 0565212, 0560112, 0560213, 0560313, 0560413, 0560513, 0560613, 0560713, 0560813, 0560913, 0561013, 0561113, 0561213, 0561313, 0561413, 0561513, 0561613, 0561713, 0561813, 0561913, 0562013, 0562113, 0562213, 0562313, 0562413, 0562513, 0562613, 0562713, 0562813, 0562913, 0563013, 0563113, 0563213, 0563313, 0563413, 0563513, 0563613, 0563713, 0563813, 0563913, 0564013, 0564113, 0564213, 0564313, 0564413, 0564513, 0564613, 0564713, 0564813, 0564913, 0565013, 0565113, 0565213, 0560113, 0560214, 0560314, 0560414, 0560514, 0560614, 0560714, 0560814, 0560914, 0561014, 0561114, 0561214, 0561314, 0561414, 0561514, 0561614, 0561714, 0561814, 0561914,0562014, 0562114, 0562214, 0562314, 0562414, 0562514, 0562614, 0562714, 0562814, 0562914  Model-F00256-256 Medium thermophore Plus lot codes:  2562712, 2562812, 2562912, 2563012, 2563112, 2563212, 2563312, 2563412, 2563512, 2563612, 2563712, 2563812, 2563912, 2564012, 2564112, 2564212, 2564312, 2564412, 2564512, 2564612, 2564712, 2564812, 2564912, 2565012, 2565112, 2565212, 2560112, 2560213, 2560313, 2560413, 2560513, 2560613, 2560713, 2560813, 2560913, 2561013, 2561113, 2561213, 2561313, 2561413, 2561513, 2561613, 2561713, 2561813, 2561913, 2562013, 2562113, 2562213, 2562313, 2562413, 2562513, 2562613, 2562713, 2562813, 2562913, 2563013, 2563113, 2563213, 2563313, 2563413, 2563513, 2563613, 2563713, 2563813, 2563913, 2564013, 2564113, 2564213, 2564313, 2564413, 2564513, 2564613, 2564713, 2564813, 2564913, 2565013, 2565113, 2565213, 2560113, 2560214, 2560314, 2560414, 2560514, 2560614, 2560714, 2560814, 2560914, 2561014, 2561114, 2561214, 2561314, 2561414, 2561514, 2561614, 2561714, 2561814, 2561914, 2562014, 2562114, 2562214, 2562314, 2562414, 2562514, 2562614, 2562714, 2562814, 2562914  Model F80096-096 Medium CSA Thermophore Lot codes:  0962712, 0962812, 0962912, 0963012, 0963112, 0963212, 0963312, 0963412, 0963512, 0963612, 0963712, 0963812, 0963912, 0964012, 0964112, 0964212, 0964312, 0964412, 0964512, 0964612, 0964712, 0964812, 0964912, 0965012, 0965112, 0965212, 0960112, 0960213, 0960313, 0960413, 0960513, 0960613, 0960713, 0960813, 0960913, 0961013, 0961113, 0961213, 0961313, 0961413, 0961513, 0961613, 0961713, 0961813, 0961913, 0962013, 0962113, 0962213, 0962313, 0962413, 0962513, 0962613, 0962713, 0962813, 0962913, 0963013, 0963113, 0963213, 0963313, 0963413, 0963513, 0963613, 0963713, 0963813, 0963913, 0964013, 0964113, 0964213, 0964313, 0964413, 0964513, 0964613, 0964713, 0964813, 0964913, 0965013, 0965113, 0965213, 0960113, 0960214, 0960314, 0960414, 0960514, 0960614, 0960714, 0960814, 0960914, 0961014, 096111, 40961214, 0961314, 0961414, 0961514, 0961614, 0961714, 0961814, 0961914, 0962014, 0962114, 0962214, 0962314, 0962414, 0962514, 0962614, 0962714, 0962814, 0962914

Physical Medicine Devices

2

No

Distributed within the United States, Canada, Mexico, Puerto Rico and Columbia

Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", || Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", || Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 || Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" || Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", || Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", || Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 || Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" || Used for the temporary relief of joint and muscle pain.

Item# Lot Number(s)  SL2103 1605BC02A, 1606BC02A  V'-SL2104 1605BC03A, 1606BC03A, 1607BC03A  V'-SL2105 1605BC04A, 1606BC04A, 1607BC04A  V'-SL2106 1605BC05A, 1606BC05A, 1607BC05A ASL2150 1605BC06A, 1607BC06A

Physical Medicine Devices

1

No

US Nationwide Distribution.

Medi Choice Arm Slings || ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA || ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA || ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA || ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA || ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA || Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).

Physical Medicine Devices

1

No

Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.

SONNET Mini Battery Pack CableProduct Usage: || The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

Physical Medicine Devices

2

No

Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE

Electric Wheelchairs: || a) C300 CORPUS II || b) C350 CORPUS II || c) C400 CORPUS II || d) C400 CORPUS II LR || e) C500 CORPUS II || f) C500 CORPUS II LR

a) C300, Serial Numbers: DOMESTIC: 43506329 43702293 43702295 2597000093 2597000105 2597000120  INTERNATIONAL: 43507565 43507903 43507955 43508148 43601189 43703638 43704109 43704250 43704286 43704299 43704314 43704322 43704323 43704324 43704405 460001307 461000015 461000016 461000034 461000040 461000051 461000061 461000080 461000088 461000105 461000106 461000107 461000108 461000109 461000156 461000165 461000191 461000192 461000196 461000202 461000231   b) C350, Serial Numbers: INTERNATIONAL (ONLY) 43101851 43101909 43101947 43101970 43102014 43102015 43102019 43102048 43102052 43204766  c) C400, Serial Numbers: INTERNATIONAL (ONLY) 44504301 44504476 44504523 44504595 44504713 44504785 44504871 44504887 44504915 44504926 44504985 44505112 44505113 44505285 44505443 44505565 44505622 44505729 44505739 44505767 44505985 44506199 44506290 44506338 44506373 44506544 44506602 44506617 44507101 44507119  d) C500, Serial Numbers: DOMESTIC: 2555000951  INTERNATIONAL: 15004546 15503636 15503640 15503687 15503688 15503691 15503731 15503732 15503733 15503746 15503747 15503748 15503749 15702097 15702755 15702772 15702774 15702775 15702776 15702777 15702790 15702791 15702792 15702793 15702796 15702798 15702799 15702800 15702801 15702802 45501186 45501198 45501202 45501269 45501312 45501326 45501416 45501424 45501497 45501506 45501509 45501604 45501683 45501714 45501736 45501753 45501989 45502028 45502151 45502283 45502340 45502342 45700476 45700712 45700771 45701602 45702143 45703007 45703392 45703559 45703608 45703631 459000050

Physical Medicine Devices

2

No

Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE

Electric Wheelchair bases: || a) C300 || b) C350 || c) C400 || d) C500

Serial Numbers:  201520007, 201520010, 201520012, 201520008, 201520009, 201522040, 201520002, 201520011, 201520006, 201522046, 201522043, 201520028, 201528134, 201528139, 201520013, 201522045, 201525069, 201525109, 201524051, 201524050, 201549087, 201550012, 201550020, 201550022, 201550017, 201550028, 201550027, 201550016, 201550036, 201550014, 201551005, 201550025, 201551028, 201551030, 201550040, 201551032, 201602031, 201602030, 201603014, 201603016, 201603023, 201602034, 201602036, 201602032, 201551034, 201603029, 201603027, 201603028, 201610008, 201601018, 201610010, 201610015, 201610019, 201610022, 201610020, 201611001, 201611010, 201520027, 201610030, 201610035, 201611012, 201603025, 201611002, 201611018, 201612018, 201612020, 201613021, 201613019, 201615008, 201618017, 201616010, 201613008, 201616004, 201616005, 201616012, 201618023, 201618021, 201618018, 201618019, 201618024, 201617031, and 201618025.

Physical Medicine Devices

1

No

AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU

OTTO BOCK Kenevo knee joints Model 3C60

Serial Numbers:  201520028, 201520027, 20150026, and 201530040.

Physical Medicine Devices

1

No

AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU

OTTO BOCK Kenevo knee joints Model 3C60=ST

The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)

Physical Medicine Devices

1

No

The product was distributed nationwide in the United States and to Canada and Mexico.

Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X

The following serial numbers, which represent all units shipped: H40001 thru H40038; and I40001, I40003, I40004, I40005, I40006, I40009, I40012, I40013, I40014, I40017, I40018, and I40021.

Physical Medicine Devices

2

No

The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.

XPRT Therapy Mattress Systems: || Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). || Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. || The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.

Serial numbers: 05G066858, 05G066859, 05G071801, 05G071803, 05G077773, 05G079666, 05G089011, 05G089012, 05G092274, 05G105434, 05G106984, 05G111332, 05G117359, 05G121857, 05G125563, 05H144898

Physical Medicine Devices

2

No

The product was sent to distributors located in AL, GA, CA, IL, KS, MN, NC, PA, TX, and VA.

3G Storm Series Power Wheelchair with Power Tilt Option.

Serial Numbers: 5927, 5930, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 5942, 5943, 5944, 5945, 5947, 5948, 5949, 5950, 5951, 5954, 5955, 5956, 5959, 5960, 5961, 5962, 5964, 5965, 5970, 5971, 5972, 5973, 5974, 5975, 5977, 5978, 5979, 5980, 6015, 6016, 6020, 6027, 6028, 6031, 6032.

Physical Medicine Devices

1

No

Nationwide

Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.

Product number BL120M, with the letters, ''SPS'' etched into the product

Physical Medicine Devices

1

No

Nationwide

SPS Blue Line Tube Clamp Adapters, Product No. BL120M

NX Workstation Software is sold in the following packages: 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405

Physical Medicine Devices

3

No

Nationwide

CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).

Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.

Physical Medicine Devices

Unclassified

No

Nationwide Distribution.

Gebauer's Fluro-Ethyl¿ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. || Gebauer's Fluro-Ethyl¿ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.

Serial Numbers: E77020080701AE, E77020080701AF, E78020080703AB, E78020080703AC, E77020080701AC, E78020080703AD, E77020080701AD,  E77020080701AA, E77020080701AB, E76020080704AA, E78020080704AA,  E77020080704AE, E77020080704AA, E77020080704AB, E77020080704AC, E78020080703AA, E78020080705AB, E78020080705AA, E76020080709AB, E78020080709AA, E76020080709AA, E78020080709AB, E77020080709AA,  E77020080709AB, E77020080709AC, E77020080709AD, E78020080712AD, E77020080711AA, E77020080712AA, E77020080709AE, E78020080711AB, E78020080712AC, E76020080712AA, E78020080711AA, E78020080712AA, E78020080712AB, E77020080704AD, E78020080715AD, E76020080716AC, E77020080716AF, E78020080715AE, E78020080715AF, E78020080715AG, E78020080716AA, E76020080716AB, E77020080716AA, E77020080716AB, E78020080716AC, E76020080716AA, E78020080716AB, E77020080714AA, E77020080714AB, E77020080714AC, E77020080714AD, E77020080714AE, E78020080707AA, E78020080715AA, E78020080715AB, E78020080715AC,  E78020080719AA, E77020080716AC, E77020080716AD, E76020080722AA, E78020080719AB, E78020080723AA, E77020080723AB, E77020080723AA, E78020080722AA, E77020080722AA, E77020080723AC, E77020080723AD, E77020080716AE, E77020080716AG, E78020080724AD, E78020080724AE,  E78020080724AB, E76020080723AA, E77020080723AE, E78020080724AA, E77020080724AA, E78020080724AC, E78020080723AB, E78020080723AC, E77020080724AB, E77020080725AC, E78020080725AA, E77020080725AA,  E77020080725AB, E78020080728AB, E77020080728AA, E78020080728AA,  E76020080730AA, E77020080730AA, E76020080730AB, E77020080731AB, E78020080802AB, E77020080802AD, E78020080802AA, E78020080802AC, E78020080801AB, E77020080802AB, E77020080802AC, E78020080801AC,  E77020080801AF, E77020080801AA, E78020080716AD, E78020080801AA, E78020080802AD, E77020080801AB, E77020080801AC, E77020080801AD,  E77020080801AE, E77020080804AA, E78020080802AE, E77020080804AC, E78020080804AB, E78020080804AA, E77020080804AB, E77020080806AA, E76020080731AA, E77020080731AA, E77020080802AA, E77020080809AA,  E77020080809AB, E78020080806AF, E77020080806AB, E78020080806AA, E77020080809AC, E78020080809AC, E78020080809AA, E78020080806AB, E78020080806AC, E78020080806AD, E78020080806AE, E78020080809AB,  E76020080809AA, E76020080811AA, E77020080811AA, E78020080812AA, E78020080812AB, E78020080812AC, E78020080812AD, E78020080812AF, E78020080811AA, E78020080812AE, E78020080812AG and E78020080812AH. The code is located underneath the seat of the chair.

Physical Medicine Devices

1

No

Worldwide Distribution including USA and countries of Spain and Great Britain.

Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. || The product is used as a hip strap chair for children.

Lot Numbers: Y8739, Y8296, Y7619, Y7004, Y5966 and Y3169.

Physical Medicine Devices

1

No

Nationwide Distribution

Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" || Model: 72108

Lot Numbers: Y3356 and Y3170.

Physical Medicine Devices

1

No

Nationwide Distribution

Alimed Gait Belt (Transfer Aid) Antimicrobial Plastic Buckle, 70" || Model: 72109

Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.

Physical Medicine Devices

1

No

The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.

Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. || Pediatric Prosthetic Device used by Lower Limb amputees.

Lot Numbers: 969A01, 969A02, 969A03, 969A04, 969A05, 968B01, 968B02, 100126171-01 and samples.

Physical Medicine Devices

1

No

Nationwide Distribution

Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. || Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.

All serial numbers

Physical Medicine Devices

2

No

Nationwide Canada

Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.

Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD. Serial Numbers: 08BE000082; 08BE000088; 08BE000089; 08BE000090; 08BE000323; 08BE001102; 08BE001105; 08BE002283; 08BE002803; 08BE003025; 08BE003250; 08BE003251; 08BE003472; 08BE003473; 08BE003632; 08BE004402; 08BE004414; 08BE004415; 08BE004835; 08BE005297; 08DE002040; 08EE000277; 08EE001539; 08EE001540; 08EE001775; 08FE003254; 08FE003257; 08FE003668; 08FE004681; 08GE003570; 08GE003936; 08HE001169; 08HE005013; 08IE001081; 08IE001316 & 08IE002729.

Physical Medicine Devices

2

No

Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.

Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD

Recalled chairs include the following Models : Recalled chairs include the following:   2008 Model Numbers:  653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner.   2009 Model Numbers:  6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.  Recalled model numbers are as folows:  6530-02, 6530-03, 6530-03-TB, 6530-04, 6530-06, 6530-07, 6530-08, 6530-08-TB-00-PB, 6530-14, 6530-15, 6530-15-00-00-00-00-LC, 6530-15-00-00-PB, 6530-16, 6530-17, 6530-17-TB, 6530-25, 65302N,  65302NT,  6530-30, 6530-31, 6530-33, 6530-37-00-00-PB, 6530-39, 6530-39-00-00-PB, 65303N,  65303N,  65304N,  65304NH,  65304NHT,  65304NT,  6530-63, 6530-63-TB, 65306N,  65306NH,  65307N,  65307NT,  65308N,  65308NT,  65314N,  65314NH,  65314NT,  65315N,  65316N,  65317N,  65317NT,  65330N,  65333NT,  65337N,  65341N,  65344N,  65360N,  65361N,  65362N,  65362NT,  65363N,  65363NT,  6540-02, 6540-03, 6540-04, 6540-04-00-HM, 6540-06, 6540-07, 6540-08, 6540-14, 6540-16-TB, 6540-17, 6540-17-TB, 65402N,  65402NT,  6540-30-00-00-PB, 6540-37, 6540-39, 6540-39-00-00-PB, 65403N,  65403NT,  65404N,  65404NH,  65404NHT,  6540-60, 6540-63-TB, 65406N,  65406NH,  65407N,  65408N,  65414N,  65414NT,  65415N,  65416N,  65417N,  65417NT,  65430N,  65437N,  65441N,  65442N,  65461NH,  65462N,  65465N,  6550-02, 6550-03, 6550-03-00-HM, 6550-04, 6550-06, 6550-13, 6550-14, 6550-14-00-00-PB, 6550-14-00-HM, 6550-16, 6550-17, 65502N,  6550-30-00-HM, 6550-34-00-00-PB, 6550-37, 6550-39-00-HM, 65503N,  65503NH,  65504N,  65504NL,  65504NT,  65504NT-DART,  65506N,  65506NH,  65507N,  65507NH,  65508N,  65514N,  65514NH,  65514NL,  65514NW,  65515N,  65516N,  65516NH,  65516NT,  65517N,  65517NCE,  65517NH,  65517NHT,  65525N,  65527N,  65527NH,  65528NH,  65530NH,  65532N,  65532NH,  65533N,  65537N,  65539N,  65539NH,  65541NL,  65544NW,  65561NL,  65562NH,  65562NL,  65567N,  65567NH,  6570-02, 6570-03, 6570-03-00-HM, 6570-07, 6570-14, 6570-14-00-00-PB, 6570-14-00-HM, 6570-17, 6570-17-00-00-PB, 6570-17-00-00-PC, 6570-17-TB,  65702N,  65702NT,  6570-39-00-HM,  65703N,  65703NH,  6570-41,  65704N,  65704NT,  6570-62, 6570-63-TB,  65706N ,  65706NH,  65707N,  65707NH,  65708N,  65708NT,  65714N,  65714NH,  65714NL,  65714NT,  65714NW,  65715N,  65716NH,  65717N,  65717NCE,  65717NH,  65725N,  65727NH,  65728NH,  65730N,  65730NH,  65732N,  65732NH,  65733N,  65737N,  65739N,  65739NH,  65741NH,  65741NL,  65761N,  65762N,  65762NH,  65762NL,  65763NH,  65766N,  65767NH,  6900-02, 6900-03, 6900-04, 6900-17, 69002N ,  6900-30, 6900-39 ,  69003N,  69003NH,  6900-41,  69004N,  6900-60, 6900-61, 6900-62, 6900-63, 6900-63-00-HM, 6900-63-TB,  69006N,  69007N,  69008N,  69008NH,  69014N,  69014NT,  69014NW,  69015N,  69016N,  69016NT,  69017N,  69017NH,  69026N,  69027N,  69028N,  69030N,  69030NH,  69031N,  69032N,  69033N,  69034N,  69037N,  69039N,  69041N,  69041NH,  69060N,  69062N,  69063N,  69063NH,  69063NT,  69065NT,  69066N,  69066NT,  69067N,  6910-03, 6910-06, 6910-17, 6910-32, 6910-33-00-HM, 6910-37-00-00-PB, 6910-37-TB, 6910-39,  69103N,  69104N,  6910-60, 6910-61, 6910-62, 6910-63,  69106N,  69107NT,  69114N,  69114NW,  69117N,  69117NH,  69117NT,  69127N,  69133N,  69133NT,  69134N,  69137N,  69162N,  69163N,  69167N,  6940-03, 6940-03-00-HT, 6940-04-TB-HT, 6940-06, 6940-06-TB-HM, 6940-07-TB, 6940-14, 6940-14-TB, 6940-15, 6940-15-00-HM, 6940-16, 6940-16-TB-HM, 6940-17, 6940-17-00-HM, 6940-17-TB-HM, 6940-19-TB-HM, 6940-26-TB, 6940-26-TB-HM, 6940-27-TB-HM, 69402N,  69402NT,  6940-30, 6940-32, 6940-32-TB, 6940-33-TB-HM,  69403N,  69403NH,  69403NT,  69403NW,  6940-41-TB-HM,  69404N,  69404NDH,  69404NH,  69404NHT,  69404NT,  69404NWT,  6940-60-TB-HT, 6940-62, 6940-62-TB, 6940-62-TB-HM, 6940-62-TB-HT, 6940-63-TB, 69406N,  69406NH,  69407N ,  69407NT,  69414N,  69414NH,  69414NT,  69415N,  69415NH,  69415NHT,  69416N,  69416NHT,  69416NT,  69417N,  69417NHT,  69417NT,  69417NW,  69419NHT,  69427NHT,  69429NT,  69430NH,  69432N,  69432NT,  69433N,  69433NH,  69433NHT,  69433NT,  69434N,  69434NHT,  69437NH,  69437NHT,  69441NHT,  69444ND,  69444NDH,  69460N,  69460NHT,  69460NWT,  69461NH,  69462N,  69462NHT,  69462NT,  69463N,  69463NH,  69463NT,  69463NWT,  69466NWT,  69467N,  6950-03, 6950-03-00-HT, 6950-04-00-HM, 6950-04-TB-HT, 6950-06-TB-HM, 6950-15, 6950-16-TB-HM, 6950-19-TB-HM, 6950-19-TB-HT, 6950-26-TB-HM, 6950-27-TB-HM, 69502NH,  6950-33, 6950-33-TB-HM, 6950-39-00-HM,  69503N,  69503N,  69503NH,  69503NT,  6950-41-00-HT,  69504N,  69504NH,  69504NW,  6950-60, 6950-60-TB-HT, 6950-62-00-00-PB, 6950-62-TB-HT, 69506NHT,  69514N,  69514NH,  69514NHT,  69514NT,  69515N,  69515NH,  69516N,  69516NHT,  69516NT,  69517N,  69517NH,  69517NHT,  69517NT,  69519NHT,  69527NHT,  69529NT,  69530NH,  69532N,  69532NT,  69533N,  69533NH,  69533NHT,  69534N,  69541NHT,  69544ND,  69560N,  69560NHT,  69560NWT,  69561N,  69561NH,  69562N,  69562NHT,  69563NH,  69563NWT.

Physical Medicine Devices

1

No

Worldwide Distribution - USA (all states except Vermont and Nebraska) and the countries of Belgium, Canada, Chile, Ireland, Kuwait, Netherlands, Saud Arabia, Singapore and United Arab Emirates.

Recalled chairs include the following: || 2008 Model Numbers: || 653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, || 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner. || 2009 Model Numbers: || 6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.

Serial number ranges: RRFK00036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRFK00254; RRFK00256-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; RRJK0001; RRIK00003; RRIK00004; RRFK00234; RRFK00236; RRFK00285; RRFK00286; and RRJK00002

Physical Medicine Devices

2

No

Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia

RotoProne Therapy System, Model 209500, Device List Number E232632 || Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.