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).
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 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:
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