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FDAFDA · Food and drugs·Recall number Z-2220-2016

The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.

Published July 27, 2016 · Recall initiated: June 14, 2016

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

WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
WalkMed Infusion, LLC
Distributor
Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.
Lot
PCF15045R, PFA13002, PFA13005, PFA13006, PFA13007, PFA13008, PFA13009, PFA13010, PFA13011, PFA13012, PFA13013, PFA13014, PFA13015, PFA13016, PFA13017, PFA13018, PFA13019, PFA13020, PFA13021, PFA13022, PFA13023, PFA13024, PFA13025, PFA13026, PFA13027, PFA13028, PFA13029, PFA13030, PFA13031, PFA13032, PFA13033, PFA13034, PFA13035, PFA13036, PFA13037, PFA13038, PFA13039, PFA13040, PFA13041, PFA13042, PFA13043, PFA13044, PFA13045, PFA13046, PFA13047, PFA13048, PFA13049, PFA13050, PFA14001, PFA14002, PFA14003, PFA14004, PFA14005, PFA14006, PFA14007, PFA14008, PFA14009, PFA14010, PFA14011, PFA14012, PFA14013, PFA14014, PFA14015, PFA14016, PFA14017, PFA14018, PFA14019, PFA14020, PFA14021, PFA14022, PFA14023, PFA14024, PFA14025, PFA14026, PFA14027, PFA14028, PFA14029, PFA14030, PFA14031, PFA14032, PFA14034, PFA14035, PFA14036, PFA14037, PFA14038, PFA14039, PFA14040, PFA14041, PFA14042, PFA14043, PFA14044, PFA14045, PFA14046, PFA14047, PFA14048, PFA14049, PFA14050, PFA14051, PFA14052, PFA14053, PFA14054, PFA14055, PFA14056, PFA14057, PFA14058, PFA14059, PFA14060, PFA15001, PFA15002, PFA15003, PFA15004, PFA15005, PFA15006, PFA15007, PFA15008, PFA15009, PFA15010, PFA15011, PFA15012, PFA15013, PFA15014, PFA15015, PFA15016, PFA15017, PFA15018, PFA15019, PFA15020, PFA15021, PFA15022, PFA15023, PFA15024, PFA15025, PFA15026, PFA15027R, PFA15028, PFA15029, PFA15030, PFA15031, PFA15032, PFA15033, PFA15035, PFA15036, PFA15037, PFA15038, PFA15039, PFA15041, PFA15043, PFA15044, PFA15045, PFA15046, PFA15047, PFA15050R, PFA15051, PFA15052, PFA15053, PFA15054, PFA15055, PFA15056, PFA15057, PFA15058, PFA15059, PFA15060, PFA15061, PFA15062, PFA15063, PFA15064, PFA15065, PFA15066, PFA15067, PFA15068, PFA15069, PFA15070, PFA15071, PFA15072, PFA15073, PFA15074, PFA15075, PFA15076, PFA15077, PFA15078, PFA15079, PFA15080, PFA15081, PFA15082, PFA15083, PFA15084, PFA15085, PFA15086, PFA15087, PFA15088, PFA15089, PFA15090, PFA15091, PFA15092, PFA15093, PFA15094, PFA15095, PFA15096, PFA15097, PFA15098, PFA15099, PFA15100, PFB13001, PFB13002, PFB13003, PFB13004, PFB13005, PFB13006, PFB13007, PFB13008, PFB13009, PFB13010, PFB13011, PFB13012, PFB13013, PFB13014, PFB13015, PFB13016, PFB13017, PFB13018, PFB13019, PFB13020, PFB13021, PFB13022, PFB13023, PFB13024, PFB13025, PFB13026, PFB13027, PFB13028, PFB13029, PFB13030, PFB13031, PFB13032, PFB13033, PFB13034, PFB13035, PFB13036, PFB13037, PFB13038, PFB13039, PFB13040, PFB13041, PFB13042, PFB13043, PFB13044, PFB13045, PFB13046, PFB13047, PFB13048, PFB13049, PFB13050, PFB15001, PFB15002, PFB15003, PFB15004, PFB15005, PFB15006, PFB15007, PFB15008, PFB15009, PFB15010, PFB15011, PFB15012, PFB15013, PFB15014, PFB15015, PFB15016, PFB15017, PFB15018, PFB15019, PFB15020, PFB15021, PFB15022, PFB15023, PFB15024, PFB15025, PFB15026, PFB15027, PFB15028, PFB15029, PFB15030, PFB15031, PFB15032, PFB15033, PFB15034, PFB15035, PFB15036, PFB15037, PFB15038, PFB15039, PFB15040, PFB15041, PFB15042, PFB15043, PFB15044, PFB15045, PFB15046, PFB15047, PFB15048, PFB15049, PFB15050, PFB15051, PFB15052, PFB15053, PFB15054, PFB15055, PFB15056, PFB15057, PFB15058, PFB15059, PFB15060, PFB15061, PFB15065R, PFB15066, PFB15068, PFB15069, PFB15070, PFB15071, PFB15072, PFB15073, PFB15074, PFB15075, PFB15076, PFB15077, PFB15078, PFB15079, PFB15080, PFB15081, PFB15082, PFB15083, PFB15084, PFB15085, PFB15086, PFB15087, PFB15088, PFB15089, PFB15090, PFB15091, PFB15092, PFB15093, PFB15094R, PFB15095, PFB16001, PFB16002, PFB16003, PFB16004, PFB16005, PFB16006, PFB16007, PFB16008, PFB16009, PFB16010, PFB16011, PFB16012, PFB16013, PFB16014, PFB16015, PFB16016, PFB16017, PFB16018, PFB16019, PFB16020, PFB16021, PFB16022, PFB16023, PFB16024, PFB16025, PFB16026, PFB16027, PFB16028, PFB16029, PFB16030, PFB16031, PFB16032, PFB16033, PFB16034, PFB16035, PFB16036, PFB16037, PFB16038, PFB16039, PFB16040, PFB16041, PFB16042, PFB16043, PFB16044, PFB16045, PFB16046, PFB16047, PFB16048, PFB16049, PFB16050, PFB16051, PFB16052, PFB16053, PFB16054, PFB16055, PFB16056, PFB16
Risk classification
Class II
Area (FDA)
device
Country
United States

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