Recall Z-0002-06 ยท FXY Hood, Surgical
VIASYS Med Systems
Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, 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
| Date | Oct 4, 2005 (initiated Sep 13, 2005) |
| Status | Terminated |
| Reason | The packaging may be compromised such that sterility of the hoods cannot be guaranteed. |
| 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 | 125 cases |
| Distribution | Nationwide and internationally to Japan, Chile and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910515 | FREEDOM MARK III SURGICAL HELMET SYSTEM Stackhouse Assoc., May 6, 1991 |