Recall Z-0892-04 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
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
| Date | Jul 20, 2004 (initiated Mar 26, 2004) |
| Status | Terminated |
| Reason | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. |
| Root cause | Other |
| Action | Consignees were notified by letter on 3/26/2004. |
| Quantity | 520 units |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982215 | MANUAL RESUSCITATOR WITH ACE Medical Marketing Concepts, Sep 18, 1998 |