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
FDA Recall Z-0001-06 · Posted 2005-10-04
Recalling FirmVIASYS Med Systems
Recall StatusTerminated
Product CodeFXY
Date Initiated2005-09-13
Date Terminated2005-12-30
Product Quantity481 cases
Reason for Recall
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and internationally to Japan, Chile and Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.