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
- Company
- Viasys Med Systems
- Recall Initiated
- September 13, 2005
- Posted
- October 4, 2005
- Terminated
- December 30, 2005
- Recall Number
- Z-0001-06
- Quantity
- 481 cases
- Firm Location
- Wheeling, IL
Reason for Recall
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
Distribution
Nationwide and internationally to Japan, Chile and Switzerland
Lot / Code Info
Part #10450, Catalog # SA-500/US, lot number 16963
Root Cause
Other
Action Taken
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.
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