STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX.
FDA Recall Z-0895-04 · Posted 2004-07-20
Recalling FirmVentlab Corporation
Recall StatusTerminated
Product CodeBTM
Date Initiated2004-03-26
Date Terminated2004-07-07
Product Quantity60 units
Reason for Recall
In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
Firm Action
Consignees were notified by letter on 3/26/2004.
Root Cause
Other
Distribution Pattern
CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.