FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0002-06
- Recalling firm
- VIASYS Med Systems
- Product
- 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
- Status
- Terminated
- Initiated
- 2005-09-13
- Posted
- 2005-10-04
- Terminated
- 2005-12-30
- 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
- Lot, serial or model codes
- Part #10567, Catalog # SA-300/US, lot number 19253
- 510(k) numbers
- ["K910515"]
- PMA numbers
- not on file
- Product code
- FXY
- Firm FEI
- 3011270181
- Firm city
- Wheeling
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28