FDA Enforcement
Class II
Terminated
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled 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-0193-2014
·
Reported November 20, 2013
Enforcement
- Recall Number
- Z-0193-2014
- Event ID
- 66624
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 20, 2013
- Initiation Date
- October 23, 2013
- Classification Date
- November 8, 2013
- Termination Date
- July 18, 2014
- Address
- 6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States
Description
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled 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
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.
Code Info
Catalog Number 5762 Lot Numbers 0677300
Distribution
Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
Quantity
90 units