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Recall Observatory FDA recall evidence

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

October 23, 2013

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
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

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate