Recall Z-2793-2018— NxStage Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by NxStage Medical, Inc., initiated 2018-06-11, terminated 2020-04-28. It names one FDA 510(k) clearance: K071263. Product: 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.. 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..
- Recalling firm
- NxStage Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-11
- Terminated
- 2020-04-28
- Firm location
- Lawrence, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.