Device product
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
Z-1122-2014
Product summary
- Event
- Event 67545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 797
- Official record key
device-enforcement:Z-1122-2014
Official wording
Reason: WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.
Code information: 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,PFA14033,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,PFK13106,PFK13107,PFK13108,PFK13109,PFK13110,PFK13111,PFK13112,PFK13113,PFK13114,PFK13115,PFK13116,PFK13117,PFK13118,PFK13119,PFK13120,PFK13121,PFK13122,PFK13123,PFK13124,PFK13125,PFK13126,PFK13127,PFK13128,PFK13129,PFK13130,PFK13131,PFK13132,PFK13133,PFK13134,PFK13135,PFK13136,PFK13137,PFK13138,PFK13139,PFK13140,PFK13141,PFK13142,PFK13143,PFK13144,PFK13145,PFL13001,PFL13002,PFL13003,PFL13004,PFL13005,PFL13006,PFL13007,PFL13008,PFL13009,PFL13010,PFL13011,PFL13012,PFL13013,PFL13014,PFL13015,PFL13016,PFL13017,PFL13018,PFL13019,PFL13020,PFL13021,PFL13022,PFL13023,PFL13024,PFL13025,PFL13026,PFL13027,PFL13028,PFL13029,PFL13030,PFL13031,PFL13032,PFL13033,PFL13034,PFL13035,PFL13036,PFL13037,PFL13038,PFL13039,PFL13040,PFL13041,PFL13042,PFL13043,PFL13044,PFL13045,PFL13046,PFL13047,PFL13048,PFL13049,PFL13050,
Distribution pattern: US Distribution including the states of IL, MA, KS, and, NJ.
Derived failure modes
-
Unknown
WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.