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.
Reported: November 20, 2013 Initiated: October 23, 2013 #Z-0196-2014
Product Description
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.
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
- 40 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" 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.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 40 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-0196-2014.
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