ESPRIT VENTILATOR, Model V1000
FDA device recall Z-0951-03 · posted 2003-07-01 · Terminated
Recall details
- Recalling firm
- Respironics California Inc
- Reason for recall
- Material hardness on original design check valve may cause premature failure.
- Action taken
- Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.
- Root cause
- Other
- Status
- Terminated
- Product code
- CPK
- Quantity affected
- 749
- Distribution
- Throughout the US and to Vietnam,Turkey, Thailand, Spain, Singapore, Puerto Rico, Philipines, Peru, Panama, Pakistan, Mexico, Malaysia, Korea, Japan, Italy, Indonesia, Egypt, Columbia, China, Canada,
- Date initiated
- 2001-06-08
- Date posted
- 2003-07-01
- Date terminated
- 2004-05-11
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESPRIT VENTILATOR (K981072) | Respironics, Inc. | 1998-11-12 |