LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, 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 is classified as FDA Class II and involves a potential sterile barrier breach in a medical device, which poses a risk of harm (infection) even though no injuries have been reported.
Plain-English summary
LivaNova is recalling specific 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, 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 involves 54 units of the SORIN GROUP SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA. The distribution was nationwide. Affected lot numbers include 1620000113, 1622400049, 1624300090, 1631200072, 1632100059, 1632800059, 1633300054, 1705100057, and 1711500053.
The FDA has classified this recall as Class II. The source text does not report any illnesses or injuries associated with this defect. Healthcare providers and consumers should stop using the affected products and contact LivaNova or their supplier for instructions on return or replacement.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 54
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 (9)
- Lot Numbers: 1620000113
- 1622400049
- 1624300090
- 1631200072
- 1632100059
- 1632800059
- 1633300054
- 1705100057
- 1711500053
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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