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

AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular… — recall Z-2147-2016

U.S. FDA — Device Enforcement · United States · 2016-06-22 · Class II

As described by U.S. FDA — Device Enforcement: AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2147-2016
Date of alert
2016-06-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sorin Group USA, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.
Reported risk: Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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