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

Recall Z-2871-2017 — Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

U.S. FDA — Device Enforcement · United States · 2017-06-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2871-2017
Date of alert: 2017-06-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sorin Group USA, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 1407000078

Reported risk: Identification of excess plastic on the tip of the cannula.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-2871-2017 — Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

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