Recall Z-0898-2007 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Surge Medical Solutions, LLC
Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S.
| 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 |