FDA recall Z-0350-2018

Product

Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.

Reason for recall

Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2017-04-06

Report date

2018-01-24

Termination date

2019-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0350-2018