Ventlab Corporation 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Ventlab Corporation
Lot Codes / Batch Numbers
Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06
Products Sold
Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06
Ventlab Corporation is recalling STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Pati due to In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
Recommended Action
Per FDA guidance
Consignees were notified by letter on 3/26/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026