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Terminated

Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP

FDA Recall Z-1085-05 · Posted 2005-08-06

Recalling FirmPuritan Bennett
Recall StatusTerminated
Product CodeCBK
Date Initiated2005-04-20
Date Terminated2012-01-25
Product Quantity309

Reason for Recall

Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.

Firm Action

Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.

Root Cause

Other

Distribution Pattern

USA, Canada and Europe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)Puritan Bennett Corp. · 1998-04-30

Official Source

View FDA Recall →

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

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