LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because included 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 involves 632 units of the Sorin Group Smart Perfusion Pack, Smart Venous Vacuum, distributed nationwide.
Healthcare providers and patients should stop using the affected Perfusion Tube Sets and contact LivaNova or their supplier for instructions on returning or replacing the products.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 632
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: 1620200038
- 1621700037
- 1622800048
- 1623100036
- 1623700036
- 1625700047
- 1627900048
- 1630500054
- 1630600077
- 1631900048
- 1632700043
- 1633500024
- 1701000056
- 1701600055
- 1701800042 1704500037
- 1705300070
- 1706100042
- 1707600055
- 1706600103
- 1707900056
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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