Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow and O2 supply tubing; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83167
This recall has been terminated (originally issued October 15, 2003).
- Company
- Viasys Med Systems
- Recall Initiated
- September 10, 2003
- Posted
- October 15, 2003
- Terminated
- March 24, 2004
- Recall Number
- Z-0038-04
- Quantity
- 1840 units
- Firm Location
- Wheeling, IL
- Official Source
- View on FDA website ↗
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-83167, lots 11385 and 11541
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.