The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper

FDA device recall Z-2220-2016 · posted 2016-07-18 · Terminated

Recall details

Recalling firm

WalkMed Infusion, LLC

Reason for recall

WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).

Action taken

WalkMed sent an Urgent : Medical Device Recall letter dated June 14, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by Users: WalkMed recommends the following actions be taken with respect to the recalled product: Our records indicate that you have received Triton pumps. Immediately review your inventory and determine whether you have any of the Triton or Triton fp infusion pumps (model numbers 300000 and 400000). Please complete and promptly return the enclosed recall response form, even if you do not have any affected stock subject to this recall notice. WalkMed recommends that users stop use of and replace the Triton and Triton fp Infusion pumps with alternative devices as soon as possible. To ensure that patients who use WalkMed Triton infusion pumps can continue to receive infusion therapies without interruption, WalkMed will support customers in their transition to alternative devices. To ensure continuity of patient care, WalkMed will continue to provide IV administration sets to existing customers, provide preventive maintenance and service for distributed pumps and make available any parts necessary for the repair or service of units for up to 3 months from the date of this recall notice. Contact WalkMed at (303) 420-9569 to arrange for shipment of the product being returned. If an owner of a Triton or Triton fp infusion pump is interested in information about options for a replacement product, please contact WalkMed. For further questions please call (303) 420-9569.

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

2966 units

Distribution

Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.

Date initiated

2016-06-14

Date posted

2016-07-18

Date terminated

2017-04-28

Location

Englewood, CO

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