Z-0001-06

Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire...

Name: Z-0001-06 Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire...
Creator: VIASYS Med Systems
Published: 2005-09-13
License: https://open.fda.gov/license/

Halyard Health / initiated 2005-09-13 / Terminated / root cause: packaging

FDA source

VIASYS Med Systems began a recall of Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic... on 2005-09-13. The reason FDA records is "The packaging may be compromised such that sterility of the hoods cannot be guaranteed". 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-0001-06
Status: Terminated
Initiated: 2005-09-13
Posted: 2005-10-04
Terminated: 2005-12-30
Recalling firm: Halyard Health
Product: Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Product code: FXY Hood, Surgical
Reason for recall: The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
Root cause tag: packaging
FDA root cause: Other
Action: VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/13/05. The accounts were informed of the potential for compromised packages seals and questionable sterility, and were instructed to check their inventory for the affected catalog numbers and lots numbers. The accounts were instructed to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange for the return goods authorization. The dealers were requested to sub-recall the affected product from their customers.
Quantity in commerce: 481 cases
Distribution: Nationwide and internationally to Japan, Chile and Switzerland
Product codes and lots: Part #10450, Catalog # SA-500/US, lot number 16963

Product code FXY

K910515Class IIFreedom Mark III Surgical Helmet SystemStackhouse Assoc. / cleared 1991-05-06

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)