Recall Z-0194-2014— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2013-10-23, terminated 2014-07-18. It names one FDA 510(k) clearance: K934127. Product: Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.. Reason: 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..
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-23
- Terminated
- 2014-07-18
- Firm location
- Ann Arbor, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.