Z-2793-2018 Class II Terminated
FDA device recall Z-2793-2018 was initiated by NxStage Medical, Inc. on June 11, 2018 and is designated Class II. 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… The recall status is terminated (terminated April 28, 2020). Affected quantity: 14975.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- June 11, 2018
- Termination Date
- April 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14975
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the countries of Australia, Canada, France, Germany, Italy, Kuwait, Netherlands, Saudi Arabia, Spain, Sweden, and UK.
Code Information
All units are affected. As of 6/11/18, the last serial number manufactured was W35452.