Recall Z-0893-04 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Ventlab Corporation
A.C.E. STAT-Check CO Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscitation ACE Corp., 155 Boyce Drive, Mocksville, NC 27028
| 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 | 18460 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 |