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U.S. Department of Health and Human Services

Class 1 Device Recall Volumetric Infusion Pump

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 Class 1 Recall
Volumetric Infusion Pump
see related information
Date Posted November 05, 2010
Recall Status1 Terminated on March 14, 2012
Recall Number Z-0307-2011
Recall Event ID 56750
Premarket Notification
510(K) Number
K070529 
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information Serial numbers: 1 thru 500, TR1041 through TR2559.
Recalling Firm/
Manufacturer
Walkmed Infusion LLC
96 Inverness Dr E Ste N
Centennial, Colorado 80112-5311
Consumer Instructions Discard product or return to place of purchase for a full refund or exchange
Manufacturer Reason
for Recall
Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.
FDA Determined
Cause 2
DESIGN: 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.
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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