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Terminated

Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface 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

FDA Recall Z-0671-2013 · Posted 2013-01-11

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDWF
Date Initiated2013-01-07
Date Terminated2013-08-26
Product Quantity6830 total all products

Reason for Recall

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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 (UAE).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083301X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERSTerumo Cardiovascular Systems Corp. · 2008-12-18K771499FLEXIBLE ARTERIAL CANNULAE3M Health Care, Sarns · 1977-08-16K770429CANNULAE, AORTIC, ARCH, HIGH FLOW3M Health Care, Sarns · 1977-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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