FDA Recalls Sorin 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 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are rated as Severe (4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 7,546 units of the STOCKERT Heater-Cooler System 3T, 240V/60 Hz, manufactured by Sorin Group USA, Inc. The recall is classified as Class II by the agency.
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 harm to patients using the device.
The affected units are identified by Item No. 16-02-81 and Serial No. 16S10743-16S11708. These devices were distributed domestically across all 50 U.S. states, the District of Columbia, and Puerto Rico, as well as to numerous foreign countries. Consumers and healthcare facilities should stop using the affected units and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- STOCKERT Heater-Cooler System 3T, 240V/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. 16-02-81
- Serial No. 16S10743-16S11708
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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