Z-0035-04

Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen...

Name: Z-0035-04 Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen...
Creator: VIASYS Med Systems
Published: 2003-09-10
License: https://open.fda.gov/license/

Halyard Health / initiated 2003-09-10 / Terminated

FDA source

VIASYS Med Systems began a recall of Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable... on 2003-09-10. The reason FDA records is "The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0035-04
Status: Terminated
Initiated: 2003-09-10
Posted: 2003-10-15
Terminated: 2004-03-24
Recalling firm: Halyard Health
Product: 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
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
FDA root cause: Other
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.
Quantity in commerce: 60 units
Distribution: Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia.
Product codes and lots: reorder #BLD-83144-24, lot 11679

Product code CAI

K930252Class IBabyset and Pac (Pulmonary Assist Circuit)Bird Life Design / cleared 1993-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)