Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2096-2014 — Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

U.S. FDA — Device Enforcement · United States · 2014-05-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2096-2014
Date of alert
2014-05-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Cardiovascular Systems Corporation
Product category
device
Product type
Devices
Reported risk: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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