Recall Z-2793-2018 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage Medical, Inc.
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
| Date | Jun 11, 2018 |
| Status | Terminated |
| Reason | There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse events have been reported. |
| Root cause | Use error |
| Action | On June 11, 2018, the firm distributed Medical Device Product Safety Notices to affected customers and dialysis centers. Patients were contacted either via email or UPS second day air. Dialysis centers were contacted via email. The recall communication alerted customers that the firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse health consequences or medical interventions have been reported. The firm informed customers that they were updating the User Guide to add the following new warning language: "Warning: Do not use any fl |
| Quantity | 14975 |
| Distribution | Worldwide Distribution - US Nationwide in the countries of Australia, Canada, France, Germany, Italy, Kuwait, Netherlands, Saudi Arabia, Spain, Sweden, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 Nxstage Medical, Inc., Aug 24, 2007 |