Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel Cush and Flap model number 103
FDA device recall Z-1073-2008 · posted 2008-04-24 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Action taken
- The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 20950 units
- Distribution
- The products were shipped nationwide to medical facilities.
- Date initiated
- 2007-10-15
- Date posted
- 2008-04-24
- Date terminated
- 2009-09-01
- 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 |