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 that compromise sterility.
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 packaged in pouches that may contain 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 distributed to customers as part of the LivaNova Perfusion Tube Sets. The recall is driven by the risk that the compromised sterile barrier could allow contamination of the medical devices.
Healthcare providers and patients should stop using the affected Perfusion Tube Sets and contact LivaNova or their supplier for further instructions on replacement or return.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 524
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 (20)
- Lot Numbers: 1620700048
- 1621600063
- 1623700039
- 1624500038
- 1625900047
- 1626500084
- 1627800066
- 1628500062
- 1630000040
- 1630500055
- 1631400035
- 1633300052
- 1635400049
- 1700600038
- 1702500069
- 1704500039
- 1706600107
- 1707400082
- 1708600072
- 1710800102
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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