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U.S. Department of Health and Human Services

Class 2 Device Recall Stackhouse FreedomAire Lens/Hood

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  Class 2 Device Recall Stackhouse FreedomAire Lens/Hood see related information
Date Initiated by Firm September 13, 2005
Date Posted October 04, 2005
Recall Status1 Terminated 3 on December 30, 2005
Recall Number Z-0001-06
Recall Event ID 33407
510(K)Number K910515  
Product Classification Hood, Surgical - Product Code FXY
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
Code Information Part #10450, Catalog # SA-500/US, lot number 16963
Recalling Firm/
Manufacturer		 VIASYS Med Systems
100 Chaddick Dr
Wheeling IL 60090-6006
For Additional Information Contact Ms. Stephanie Wasielewski
800-323-6305
Manufacturer Reason
for Recall		 The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FXY and Original Applicant = STACKHOUSE ASSOC.
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