Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
- Company
- Viasys Med Systems
- Recall Initiated
- September 10, 2003
- Posted
- October 15, 2003
- Terminated
- March 24, 2004
- Recall Number
- Z-0035-04
- Quantity
- 60 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-83144-24, lot 11679
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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