Device product
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
Z-0196-2014
Product summary
- Event
- Event 66624
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-0196-2014
Official wording
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 information: Catalog Number 9473 Lot Numbers 0689812
Distribution pattern: Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
Derived failure modes
-
Foreign material or chemical contamination
particulate