A.C.E. STAT-Check CO Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscita
FDA device recall Z-0893-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ventlab Corporation
- 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.
- Action taken
- Consignees were notified by letter on 3/26/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 18460 units
- Distribution
- CA
- Date initiated
- 2004-03-26
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-07
- Location
- Mocksville, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANUAL RESUSCITATOR WITH ACE (K982215) | Medical Marketing Concepts | 1998-09-18 |