LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because they may contain Medtronic display sets with packaging pinholes that could breach the sterile barrier.
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 is classified as FDA Class II, and the hazard involves a potential sterile barrier breach in medical devices, which poses a risk of infection or harm, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
LivaNova is recalling Perfusion Tube Sets (PTS) because they may contain Medtronic DLP Pressure Disposable Display Sets packaged in pouches with small pinholes. These pinholes, approximately 1mm or less in diameter, create a potential sterile barrier breach in the display sets.
The affected display sets were included with the LivaNova Perfusion Tube Sets, which were then distributed to customers. The recall is limited to Lot Number 1703700067 of the Sorin Group Smart Perfusion Pack (Ref 627376401), which is a non-sterile sample not intended for clinical use.
Customers who have received these products should stop using them and contact LivaNova or their supplier for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 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 1703700067
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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