Non-continuous ventilators accessories under the following brand names: a) REM Auto M. w/Humid, w/Smartcard A Flex US mo
FDA device recall Z-1064-2008 · 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 |
|---|---|---|
| M-SERIES PRO CPAP SYTEM (K052110) | Respironics, Inc. | 2005-10-20 |
| REMSTAR AUTO WITH C-FLEX CPAP SYSTEM (K041010) | Respironics, Inc. | 2004-05-05 |