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Terminated

Medical Air Compressor Model #8413419

FDA Recall Z-0674-2007 · Posted 2007-04-05

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBTI
Date Initiated2007-01-26
Date Terminated2007-06-15
Product Quantity67 units

Reason for Recall

Compressors not providing sufficient supply pressure to connected medical ventilator

Firm Action

The recalling firm issued a Medical Device Recall Letter dated 1/22/07 to their customers via Certified Mail. An authorized service representative will inspect each potentially affected device. If a device is found to have an affected dryer assembly, it will be repaired free of charge.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419Drager, Inc. · 1998-10-29

Official Source

View FDA Recall →

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

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