Sorin Group Recalls STOCKERT Heater-Cooler Systems Due to Hydrogen Peroxide Diffusion
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 source 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 Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Sorin Group USA, Inc. is recalling 7,546 units of the STOCKERT Heater-Cooler System 3T, 120V/60 Hz. The recall involves Item No. 16-02-85 with serial numbers ranging from 16S10958 to 16S16847. The affected units were distributed domestically across the United States and its territories, as well as in numerous foreign 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 device.
Healthcare facilities and consumers who have this product should stop using it 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, 120V/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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