Enforcement Report - Week of December 12, 2012
-
Back to Previous Page
Product Detail
| Product Description | 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. |
|---|---|
| Recall Number | Z-0461-2013 |
| Classification | Class II |
| Code Info | catalog number: 5762 and lot number: 0570466 and 0589212 |
| Product Distributed Qty | 5760 total products |
| Reason For Recall | Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. |
Event Detail
| Event Id | 63407 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Terumo Cardiovascular Systems Corporation |
| City | Ann Arbor |
| State | MI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia,United Arab Emirates (UAE), Singapore, USA, Malaysia, BELGIUM, Japan, and CANADA. |
-
