Recall Z-0181-06 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080.
| Date | Nov 23, 2005 (initiated Oct 19, 2005) |
| Status | Terminated |
| Reason | The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package. |
| Root cause | Other |
| Action | Consignees were notified via telephone, and a recall letter dated 10/19/05 sent to each consignee, beginning on 10/18/05. International affiliates were notified via email. |
| Quantity | 48 |
| Distribution | California, Indiana, Missouri, Brazil and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA 3M Health Care, Sarns, Feb 22, 1994 |