Recall Z-0896-2007 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Surge Medical Solutions, LLC
Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, handle stylet, sterile, REF CODE: RSH-M014S.
| Date | Jun 6, 2007 (initiated Apr 17, 2007) |
| Status | Terminated |
| Reason | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Root cause | Other |
| Action | Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07. |
| Quantity | 2,211 for all Recalls Z-0892-0904-2007 |
| Distribution | Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964393 | CHASE RETROGRADE CARDIOPLEGIA CANNULA Chase Medical, Inc., Apr 23, 1997 |