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Terminated

ComfortGel Nasal Mask size small

FDA Recall Z-0178-04 · Posted 2003-12-10

Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeBZD
Date Initiated2003-09-29
Date Terminated2004-03-01
Product Quantity5293 units

Reason for Recall

product does not contain built in exhalation port

Firm Action

The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The products were shipped to sleep centers nationwide and in Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954207GEL MASKRespironics, Inc. · 1996-01-31

Official Source

View FDA Recall →

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

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