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Terminated

ThermovenT 600, Heat and Moisture Exchangers Catalog # 580011

FDA Recall Z-1130-04 · Posted 2004-07-22

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBYD
Date Initiated2004-07-13
Date Terminated2012-05-08

Reason for Recall

Sterility of the device is compromised due to lack of package integrity

Firm Action

Smiths Medical notified Direct Customers were contacted via letter delivered by Federal Express on July 13, 2004. Dealers were contacted via letter starting on July 14, 2004.Users are requested to return product.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K874597THERMOVENT 600, 1200, T, 02Portex, Inc. · 1988-01-19

Official Source

View FDA Recall →

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

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