Sorin Dual Stage Venous Return Catheter Recalled for Incorrect Instructions
Sorin Group USA is recalling 60 units of Dual Stage Venous Return Catheters because the cases contained incorrect Instructions For Use (IFU).
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 2/5 (Moderate).
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 II and involves a documentation error (incorrect IFU) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sorin Group USA, Inc. is conducting a field correction for the Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number LRD-61046. The recall involves 60 units of the cardiopulmonary bypass catheter, which are packed in sealed pouches with ten pouches per case. The product has an expiration date of 10/31/2018 and is associated with lot number 1529300018.
The recall was initiated because the incorrect Instructions For Use (IFU) were packaged in the case. This documentation error could potentially lead to improper use of the medical device if the incorrect instructions are followed.
The affected products were distributed in the United States to California and internationally to Canada. Users of this medical device should stop using the product and contact Sorin Group USA, Inc. for further instructions or a replacement.
The recalled product
- Product
- Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 60
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 (1)
- lot - 1529300018
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Sorin Group USA, Inc.
See all →- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- HighSorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
FDA (Devices) · 2017-08-16
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSorin Group Recalls CDI H/S Cuvettes Due to Connection Error
FDA (Devices) · 2016-03-02
- ModerateRenovoCath RC 120 Catheter Recalled for Incorrect Instructions for Use
FDA (Devices) · 2016-01-06
- ModerateArrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide
FDA (Devices) · 2018-02-28
- ModerateSorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect
FDA (Devices) · 2016-09-14
- ModerateC.R. Bard Recalls Foley Catheters Due to Labeling Error
FDA (Devices) · 2016-04-20
- ModerateArrow International Recalls Central Venous Catheterization Kits with Incorrect Guide
FDA (Devices) · 2018-02-28