Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, rig
FDA device recall Z-0904-2007 · posted 2007-06-06 · Terminated
Recall details
- Recalling firm
- Surge Medical Solutions, LLC
- Reason for recall
- The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Action taken
- Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 2,211 for all Recalls Z-0892-0904-2007
- Distribution
- Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.
- Date initiated
- 2007-04-17
- Date posted
- 2007-06-06
- Date terminated
- 2009-03-10
- Location
- Grand Rapids, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHASE RETROGRADE CARDIOPLEGIA CANNULA (K964393) | Chase Medical, Inc. | 1997-04-23 |