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U.S. Department of Health and Human Services

Class 2 Device Recall Triton FP Infusion Pump

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 Class 2 Recall
Triton FP Infusion Pump
see related information
Date Posted March 03, 2014
Recall Status1 Open
Recall Number Z-1122-2014
Recall Event ID 67545
Premarket Notification
510(K) Number
K070529 
Product Classification Pump, Infusion - Product Code FRN
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.
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,
Recalling Firm/
Manufacturer
WalkMed Infusion, LLC
96 Inverness Drive East, Suite J
Englewood, Colorado 80112-5311
For Additional Information Contact Suzane L. Hardin
720-351-4957
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action WalkMed Infusion sent an Important Medical Device Recall letter dated February 14, 2014, to all affected customers. The letter identified the product the problem and the action customers need to take. Our records Indicate that you have purchased product affected by this recall (see the attached list).Our sales representative will contact you to determine a plan for label replacement for your units. Replacement of the label will include a simple process of removing the old label (PN 300063), replacing it with a corrected label(PN 400033) and documenting completion of the replacement. This action can be completed by you,your customers,our sales representative, or by returning the infusion pump to WalkMed Infusion. For further questions please call (720) 351-4934 or (720) 351-4965. Product will be corrected in the field when possible and supported by the customer. Otherwise, WalkMed Infusion employees with travel to the customer and complete the correction activities.
Quantity in Commerce 797
Distribution US Distribution including the states of IL, MA, KS, and, NJ.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
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