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Terminated

On Site Gas Systems POGS 33C Portable Oxygen Generation System

FDA Recall Z-0647-2014 · Posted 2014-01-08

Recall StatusTerminated
Product CodeCAW
Date Initiated2013-12-19
Date Terminated2014-10-02
Product Quantity198 units

Reason for Recall

Heat exchanger hose becomes weak and may fail.

Firm Action

On Site Gas Systems issued letter on 12/19/13 and stated replacement parts to retrofit the blue Federal Heater hose with stainless steel will be provided and the letter included the Technical Bulletin TB 12-19-13-1 .

Root Cause

Device Design

Distribution Pattern

US Distribution: PA only.

Official Source

View FDA Recall →

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

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