Recall Z-0666-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
| Date | Jan 11, 2013 (initiated Jan 7, 2013) |
| Status | Terminated |
| Reason | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part. |
| Root cause | Process control |
| Action | TERUMO sent an URGENT MEDICAL DEVICE RECALL notification to all consignees on January 7, 2013. Terumo CVS is advising users to discontinue use and return all affected cannulae in inventory. Terumo CVS will issue credit for returned cannulae. Terumo CVS providied a list of marketed devices that can be used as alternatives. Contact Terumo CVS Customer Service with questions or concerns: 800- 521- 2818 Monday Friday, 8 AM - 6 PM EST For questions regarding this recall call 734-741-6173. |
| Quantity | 6830 total units for all products |
| Distribution | Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083301 | X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS Terumo Cardiovascular Systems Corp., Dec 18, 2008 |
| K770429 | CANNULAE, AORTIC, ARCH, HIGH FLOW 3M Health Care, Sarns, Mar 16, 1977 |
| K771499 | FLEXIBLE ARTERIAL CANNULAE 3M Health Care, Sarns, Aug 16, 1977 |