LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of 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 medical device with a potential sterile barrier breach, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
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 products are LivaNova Perfusion Tube Sets distributed to customers. The recall is initiated by LivaNova following notification from Medtronic regarding the packaging defect in the included display sets.
Customers should stop using the affected Perfusion Tube Sets and contact LivaNova for instructions on how to return or replace the products.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 4
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 (2)
- Lot Numbers: 1621400045
- 1628600043
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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