RecallDepth

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

Company
Viasys Med Systems
Recall Initiated
September 10, 2003
Posted
October 15, 2003
Terminated
March 24, 2004
Recall Number
Z-0036-04
Quantity
40 units
Firm Location
Wheeling, IL

Reason for Recall

The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.

Distribution

Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia.

Lot / Code Info

reorder #BLD-83120, lot 11593

Root Cause

Other

Action Taken

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.

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