LivaNova Perfusion Tube Sets Recalled Due to 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 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 display sets were distributed to customers as part of the LivaNova Perfusion Tube Sets. The recall is being conducted by Sorin Group USA, Inc. (LivaNova) based on information provided by Medtronic regarding the packaging defect.
Healthcare providers and patients should stop using the affected Perfusion Tube Sets and contact LivaNova or their supplier for further instructions on returns or replacements. The source text does not specify specific lot numbers, expiration dates, or the number of units affected.
The recalled product
- Product
- STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
- 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 1709500117
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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