Medical Device Recall: Z-0037-04

FDA Recalls dataset · Firm: VIASYS Med Systems · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-09-10 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0037-04.

Recall Res Number
Z-0037-04
Recalling Firm / Manufacturer
VIASYS Med Systems
FEI Number
3011270181
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-10
Date Posted
2003-10-15
Date Terminated
2004-03-24
Product Code
CAI
Event Number
27242
Product Quantity
340 units
Product Description Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166
Reason for Recall The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
Action Details 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.
Distribution Pattern Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia.
Code Information / Serial Numbers reorder #BLD-83166, lot 11384

Related Establishments / Registrations

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