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U.S. Department of Health and Human Services

Class 2 Device Recall Pulmanex Hyperinflation Circuit

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  Class 2 Device Recall Pulmanex Hyperinflation Circuit see related information
Date Initiated by Firm September 10, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on March 24, 2004
Recall Number Z-0036-04
Recall Event ID 27242
510(K)Number K930252  
Product Classification Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
Product Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Code Information reorder #BLD-83120, lot 11593
Recalling Firm/
Manufacturer		 VIASYS Med Systems
100 Chaddick Dr.
Wheeling IL 60090
For Additional Information Contact Ms. Stephanie Wasielewski
847-537-4601
Manufacturer Reason
for Recall		 The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
FDA Determined
Cause 2		 Other
Action VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/10-11/03, informing them of the potential for a blocked exhalation hole in the sideport relief valve cap which may result in excess pressure build-up. The accounts were instructed to check their inventory for the affected catalog numbers and lots numbers, place any found on hold for return to VIASYS, and sub-recall the affected product from their customers.
Quantity in Commerce 40 units
Distribution Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia.
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 = CAI and Original Applicant = BIRD LIFE DESIGN
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