Sorin Group Recalls STOCKERT Heater-Cooler Systems Due to Hydrogen Peroxide Risk
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems because plastic fibers may allow excessive 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (excessive chemical diffusion) are rated as Severe (4).
Plain-English summary
Sorin Group USA, Inc. is recalling 7,546 units of the STOCKERT Heater-Cooler System 3T, 127V/60 Hz. The recall involves Item No. 16-02-83 with serial numbers ranging from 16S11455 to 16S16509. The devices were distributed domestically across numerous US states and territories, as well as to numerous foreign countries.
The recall was initiated 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 of chemical exposure 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, 127V/60 Hz
- Manufacturer
- Sorin Group USA, Inc.
- 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
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.
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