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 is classified as FDA Class II. The hazard involves a potential sterile barrier breach in a medical device, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
LivaNova is recalling specific Perfusion Tube Sets (PTS) due to a potential sterile barrier breach. The issue stems from Medtronic DLP Pressure Disposable Display Sets included with the PTS, which are packaged in pouches that may contain small pinholes approximately 1mm or less in diameter.
These pinholes compromise the sterile integrity of the display sets. The affected Perfusion Tube Sets were distributed to customers nationwide. The recall involves 98 units of Sorin Group Smart Perfusion Packs and Smart Circulatory Assist Packs, identified by specific lot numbers listed in the agency record.
Healthcare providers and patients should stop using the affected Perfusion Tube Sets and contact LivaNova or their supplier for replacement or further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 98
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 (10)
- Lot Numbers: 1620000123
- 1622800056
- 1623500052m 1627700083
- 1631200074
- 1700300040
- 1701000065
- 1703700061
- 1706500063
- 1708000068
- 1717000057
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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