Recall Z-2220-2016 ยท FRN Pump, Infusion
WalkMed Infusion, LLC
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
| Date | Jul 18, 2016 (initiated Jun 14, 2016) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Device Design |
| Action | 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, eve |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070529 | AFF (MARK I) VOLUMETRIC INFUSION PUMP Definitive Medical Technologies, Ltd., May 8, 2007 |