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Terminated

CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

FDA Recall Z-1117-2022 · Posted None

Recalling FirmCaire, Inc.
Recall StatusTerminated
Product CodeCAW
Date Initiated2022-03-25
Date Terminated2023-10-05
Product Quantity2 oxygen concentrators

Reason for Recall

The device was not cleared for U.S. distribution.

Firm Action

The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summarized the information that was in the email.

Root Cause

No Marketing Application

Distribution Pattern

Distribution was made to Puerto Rico. There was no foreign/government/military distribution.

Official Source

View FDA Recall →

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

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