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 excessive hydrogen peroxide to diffuse into the blood compartment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. According to the rubric, an FDA Class II recall involving a significant hazard (excessive chemical diffusion into blood) is classified as Severe (Score 4), particularly when no specific hospitalization reports are cited to elevate it to Critical, but the risk is significant enough to warrant a high severity rating.
Plain-English summary
Sorin Group USA, Inc. is recalling 7,546 units of the STOCKERT Heater-Cooler System 3T (200V/50 Hz/60 Hz). The recall involves Item No. 16-02-85 with serial numbers ranging from 16S10958 to 16S16847. The devices were distributed domestically across numerous U.S. states and territories, as well as internationally to many countries.
The recall is being issued 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 equipment.
Healthcare facilities and consumers who possess these specific units should stop using them immediately. Users should contact Sorin Group USA, Inc. for instructions on how to return or replace the affected devices.
The recalled product
- Product
- STOCKERT Heater-Cooler System 3T, 200V/50 Hz/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. 16-02-85
- Serial No. 16S10958-16S16847
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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