Sorin Group Recalls CDI H/S Cuvettes Due to Connection Error
Sorin Group USA is recalling CDI H/S Cuvettes because they may fail to connect properly with the probe, causing the monitor to display an error and preventing blood parameter values from displaying.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a functional error preventing data display rather than a direct physical hazard.
Plain-English summary
Sorin Group USA, Inc. is recalling the CDI H/S Cuvette, a non-sterile component manufactured by Terumo Cardiovascular Group. These cuvettes are used in Heart/Lung Perfusion Packs or Smart Perfusion Packs designed for surgery requiring cardiopulmonary bypass. The recall involves 6,859 units distributed nationwide in the United States and in Canada.
The recall is being conducted because the CDI System 500 monitor may display an "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this error occurs, blood parameter values for hematocrit (HCT), hemoglobin (Hgb), and oxygen saturation (S02) do not display on the monitor.
The affected products include specific catalog numbers and lots, including Catalog Number 6922 (1/2 inch), Catalog Number 6923 (3/8 inch), and Catalog Number 6924 (1/4 inch). The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surger
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 6,859
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 (20)
- Catalog Number 6922
- 1/2 inch -lots TE27
- TH06 and TK03 Catalog Number 6923
- 3/8 inch - lots TE13
- TE18
- TG15
- TH20 and TK17 b. Model Number(s): 020204612
- 020208807
- 020210805
- 020211806
- 020493806
- 044002300
- 044003200
- 044004102
- 044004700
- 044010200
- 044016900
- 044017601
- 044018700
- 044019901
Distribution
Distributed nationwide across the United States.
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