ComfortGel Nasal Mask size small
FDA device recall Z-0178-04 · posted 2003-12-10 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- product does not contain built in exhalation port
- Action taken
- The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 5293 units
- Distribution
- The products were shipped to sleep centers nationwide and in Canada.
- Date initiated
- 2003-09-29
- Date posted
- 2003-12-10
- Date terminated
- 2004-03-01
- Location
- Murrysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEL MASK (K954207) | Respironics, Inc. | 1996-01-31 |