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.
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 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.
- 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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