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Terminated

STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX

FDA Recall Z-0892-04 · Posted 2004-07-20

Recalling FirmVentlab Corporation
Recall StatusTerminated
Product CodeBTM
Date Initiated2004-03-26
Date Terminated2004-07-07
Product Quantity520 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.

K982215MANUAL RESUSCITATOR WITH ACEMedical Marketing Concepts · 1998-09-18

Official Source

View FDA Recall →

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

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