FDA Medical Device Recalls (openFDA)
Walkmed Infusion LLC: 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.
- Recall number
- Z-0307-2011
- Recalling firm
- Walkmed Infusion 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.
- Status
- Terminated
- Initiated
- 2010-06-17
- Posted
- 2010-11-05
- Terminated
- 2012-03-14
- Reason
- Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.
- 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
- 1565 pumps
- Distribution
- Nationwide Distribution -- AL, CA, FL, and PA.
- Lot, serial or model codes
- Serial numbers: 1 thru 500, TR1041 through TR2559.
- 510(k) numbers
- K070529
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3000204189
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28