Recall Z-0035-04 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
VIASYS Med Systems
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
| Date | Oct 15, 2003 (initiated Sep 10, 2003) |
| Status | Terminated |
| Reason | The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up. |
| 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 | 60 units |
| Distribution | Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930252 | BABYSET AND PAC (PULMONARY ASSIST CIRCUIT) Bird Life Design, Feb 9, 1993 |