Home / Recalls / WalkMed Infusion, LLC / Z-1122-2014

Z-1122-2014 Class II Terminated

Recalled by WalkMed Infusion, LLC — Englewood, CO

FDA device recall Z-1122-2014 was initiated by WalkMed Infusion, LLC on February 17, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated October 6, 2014). Affected quantity: 797.

Recall Details

Product Type
Devices
Report Date
March 12, 2014
Initiation Date
February 17, 2014
Termination Date
October 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
797

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Distribution including the states of IL, MA, KS, and, NJ.

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,

Other recalls by WalkMed Infusion, LLC

  • Z-2228-2016 Class II — T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouch (June 14, 2016)
  • Z-2231-2016 Class II — T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free F (June 14, 2016)
  • Z-2221-2016 Class II — Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per (June 14, 2016)
  • Z-2234-2016 Class II — T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, w (June 14, 2016)
  • Z-2235-2016 Class II — T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Cl (June 14, 2016)
  • Z-2233-2016 Class II — T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 (June 14, 2016)
  • Z-2222-2016 Class II — T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 (June 14, 2016)
  • Z-2220-2016 Class II — The pump (with cushioning foam inserts) is packaged in a single pump box. Four p (June 14, 2016)
  • Z-2229-2016 Class II — T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 p (June 14, 2016)
  • Z-2225-2016 Class II — T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Pack (June 14, 2016)

FDA data resources