Z-1131-04

Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021

Name: Z-1131-04 Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021
Creator: Smiths Medical ASD, Inc.
Published: 2004-07-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-07-13 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD, Inc. began a recall of Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021 on 2004-07-13. The reason FDA records is "Sterility of the device is compromised due to lack of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1131-04
Status: Terminated
Initiated: 2004-07-13
Posted: 2004-07-22
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
Reason for recall: Sterility of the device is compromised due to lack of package integrity
Root cause tag: packaging
FDA root cause: Other
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.
Distribution: Nationwide
Product codes and lots: Lot Numbers 103166A, 103353A, 907001 to 912297, 001067 to 111623, K101587 to K522160

Product code BYD

K874597Class IThermovent 600, 1200, T, 02Portex, Inc. / cleared 1988-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)