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.
Reported: November 20, 2013 Initiated: October 23, 2013 #Z-0195-2014
Product Description
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.
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.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 30 units
- Distribution
- Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 30 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0195-2014.
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