The Recall Desk
SevereFDA (Devices)·Z-2773-2017·Announced 2017-08-02

Sorin Group Recalls STOCKERT Heater-Cooler Systems Due to Hydrogen Peroxide Risk

Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems 3T because plastic fibers may allow hydrogen peroxide to diffuse into the blood compartment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies this as an FDA Class II recall involving a medical device defect that allows chemical diffusion exceeding allowable limits, which aligns with the rubric criteria for a Severe (4) rating due to the potential for significant injury or adverse health consequences.

Plain-English summary

Sorin Group USA, Inc. is recalling 7,546 units of the STOCKERT Heater-Cooler System 3T, 208V/60 Hz. The recall is due to a defect in certain oxygenators where plastic heat exchanger fibers separating the blood and water compartments may allow hydrogen peroxide to diffuse into the blood compartment in quantities that exceed allowable limits.

The affected units are identified by Item No. 16-02-82 and Serial No. 16S10772-16S16840. These devices were distributed domestically across all 50 U.S. states, the District of Columbia, and Puerto Rico, as well as to numerous foreign countries.

Healthcare facilities and consumers should stop using the affected devices and contact the recalling firm for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Manufacturer
Sorin Group USA, Inc.
Category
Medical Device — Cardiovascular / Perfusion
Hazard
Affected units
7,546

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Item No. 16-02-82
  • Serial No. 16S10772-16S16840

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 6 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Sorin Group USA, Inc.

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Same hazard · chemical exposure

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