Recall Z-2772-2017— Sorin Group USA, Inc.

Name: FDA recall Z-2772-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-30

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2017-06-30, terminated 2023-10-10. It names one FDA 510(k) clearance: K052601. Product: STOCKERT Heater-Cooler System 3T, 240V/60 Hz. Reason: Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Terminated: 2023-10-10
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K052601 — STOCKERT HEATER-COOLER SYSTEM 3TSorin Group Deutschland GmbH·cleared 2006-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

STOCKERT Heater-Cooler System 3T, 240V/60 Hz

Reason for recall

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Data sourced from openFDA. This site is unofficial and independent of the FDA.