LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, 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 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 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, could 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 initiated by LivaNova following notification from Medtronic regarding the packaging defect.
Healthcare providers and customers should stop using the affected Perfusion Tube Sets and contact LivaNova for further instructions on how to return or replace the products.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 733
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: (a) 1703100033
- 1703200057
- 1705400037
- 1707900050
- 1708200042
- 1710200084
- 1713700057
- 1715900028 (b) 1619500015
- 1620300020
- 1623000025
- 1623700026
- 1624400017
- 1625100125
- 1626500068
- 1627900033
- 1628600023
- 1629400030
- 1632800035
- 1634200023
- 1634900050
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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