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Terminated

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.

FDA Recall Z-0350-2018 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2017-04-06
Date Terminated2019-07-10
Product Quantity1,150 power strips

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.

Firm Action

Merge began notify customers via an Urgent Medical Device Recall letter on 4/6/2017 via mail. The letter identified affected product, stated the issue, and informed customers that Merge would replace affected product. A response form is requested to be returned to Merge. Questions can be sent via email to [email protected]

Root Cause

Component design/selection

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152864Merge HemoMerge Healthcare Incorporated · 2016-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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