LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential sterile barrier breach in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
LivaNova is recalling Perfusion Tube Sets (PTS) because they include Medtronic DLP Pressure Disposable Display Sets that may be packaged in pouches with small pinholes. These pinholes, approximately 1mm or less in diameter, may result in a potential sterile barrier breach in the display sets.
The affected display sets were distributed to customers as part of the LivaNova Perfusion Tube Sets. The source text does not specify the number of units affected, specific distribution dates, or the geographic scope of the distribution.
Customers who have received these Perfusion Tube Sets should stop using them and contact LivaNova or their supplier for further instructions regarding the recall.
The recalled product
- Product
- NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 1
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 Number 1623100001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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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