The Recall Desk
SevereFDA (Devices)·Z-2771-2017·Announced 2017-08-02

Sorin Group Recalls STOCKERT Heater-Cooler Systems Due to Fiber Separation

Sorin Group USA is recalling STOCKERT Heater-Cooler System 3T units because plastic heat exchanger fibers may allow excessive hydrogen peroxide diffusion.

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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (exceeding allowable limits of hydrogen peroxide) are rated as Severe (4), as they are not Class I but involve a significant risk.

Plain-English summary

Sorin Group USA, Inc. is recalling 7,546 units of the STOCKERT Heater-Cooler System 3T, 230 V. The recall involves Item No. 16-02-83 with serial numbers ranging from 16S11455 to 16S16509. The affected devices were distributed domestically across numerous US states and territories, as well as in many foreign countries.

The recall is being conducted because plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow the diffusion of hydrogen peroxide in quantities that exceed allowable limits. This defect poses a risk to patients using the devices.

Healthcare facilities and consumers who possess these specific units should stop using them immediately and contact Sorin Group USA, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
STOCKERT Heater-Cooler System 3T, 230 V
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. 16-02-83
  • Serial No. 16S11455-16S16509

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.

See all →

Same hazard · chemical exposure

See all →