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U.S. Department of Health and Human Services

Class 2 Device Recall Triton Infusion Pump

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  Class 2 Device Recall Triton Infusion Pump see related information
Date Initiated by Firm October 01, 2015
Date Posted November 06, 2015
Recall Status1 Terminated 3 on July 12, 2016
Recall Number Z-0242-2016
Recall Event ID 72331
510(K)Number K070529  
Product Classification Pump, infusion - Product Code FRN
Product Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
Code Information Model numbers 300000, 400000
Recalling Firm/
Manufacturer		 WalkMed Infusion, LLC
6555 S Kenton St Ste 304
Englewood CO 80111-6838
For Additional Information Contact
303-420-9569
Manufacturer Reason
for Recall		 The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.
FDA Determined
Cause 2		 Device Design
Action A Field Notification (letter) was provided to users on 10/01/15 to remind them of the following:use air elimination filters, as appropriate, not to over program into the device the volume to be infused, remove air from the IV bag prior to starting the infusion, issues associated with the use of Venofer or similar drugs. No products are being returned.
Quantity in Commerce 4695 units
Distribution Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
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