Anestar and Anestar Plus Anesthesia System.
FDA device recall Z-0929-06 · posted 2006-06-02 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.
- Action taken
- Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 337 UNITS
- Distribution
- The units have been distributed to distributors and end-users such as hospitals and clinics nationwide. There are 3 foreign accounts in Australia, El Salvador, and Venezuela.
- Date initiated
- 2006-03-17
- Date posted
- 2006-06-02
- Date terminated
- 2006-08-01
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR (K001988) | Heyer America, Inc. | 2001-02-05 |