Z-1122-2014Class II

Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is...

Name: Z-1122-2014 Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is...
Creator: WalkMed Infusion, LLC
Published: 2014-02-17
License: https://open.fda.gov/license/

WalkMed Technologies, LLC / initiated 2014-02-17 / Terminated / root cause: labeling and UDI

FDA source

WalkMed Infusion, LLC began a recall of Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as... on 2014-02-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1122-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-17
Posted: 2014-03-03
Terminated: 2014-10-06
Recalling firm: WalkMed Technologies, LLC
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.
Product code: FRN Pump, Infusion
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1122-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-03

Product code FRN

K070529Class IIAff (Mark I) Volumetric Infusion PumpDefinitive Medical Technologies, Ltd. / cleared 2007-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)