Product Wiki · Recalls · U.S. FDA — Device Enforcement

Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. — recall Z-0195-2014

U.S. FDA — Device Enforcement · United States · 2013-10-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0195-2014
Date of alert
2013-10-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Cardiovascular Systems Corporation
Product category
device
Product type
Devices
Reported risk: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow¿ Aortic Cannulae and Sarns" Venous Return Cannulae.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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