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Terminated

Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24

FDA Recall Z-0034-04 · Posted 2003-10-15

Recalling FirmVIASYS Med Systems
Recall StatusTerminated
Product CodeCAI
Date Initiated2003-09-10
Date Terminated2004-03-24
Product Quantity2,720 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930252BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)Bird Life Design · 1993-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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