Z-0307-2011

WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications...

Name: Z-0307-2011 WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications...
Creator: Walkmed Infusion LLC
Published: 2010-06-17
License: https://open.fda.gov/license/

WalkMed Technologies, LLC / initiated 2010-06-17 / Terminated / root cause: design

FDA source

Walkmed Infusion LLC began a recall of WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as providing total parenteral nutrition... on 2010-06-17. The reason FDA records is "Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0307-2011
Status: Terminated
Initiated: 2010-06-17
Posted: 2010-11-05
Terminated: 2012-03-14
Recalling firm: WalkMed Technologies, LLC
Product: WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.
Product code: FRN Pump, Infusion
Reason for recall: Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.
Root cause tag: design
FDA root cause: Device Design
Action: All customers were notified by letter on 06/17/2010, describing the affected product and advising them of the possible malfunctioning alarm in the case a user does not follow the instructions as specified in the Triton Operation Manual. The letter also reminded all users to follow the procedures in the IFUs. The firm stated that it was best if customers re-educated all nurses on the proper door closure procedure to help prevent the potential bypass issue from occurring. Attached to the letter were two pages explaining the proper process for closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.
Quantity in commerce: 1565 pumps
Distribution: Nationwide Distribution -- AL, CA, FL, and PA.
Product codes and lots: Serial numbers: 1 thru 500, TR1041 through TR2559.

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)