LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach
LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 breach of the sterile barrier, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
LivaNova USA Inc. is recalling 96 units of Sterile Disposable Connectors (ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283) under FDA recall number Z-2452-2020. The recall is limited to Lot 2003400083.
The firm identified through internal tests that the sterile barrier of certain sterile standalone connectors may present a breach. The issue potentially affects components assembled with a specific packaging and is associated with a specific production period. The agency has classified this as a Class II recall.
The affected units were distributed to various US states and to Hospital de Barsuto in Bilbao, Spain. Consumers and healthcare facilities should stop using the affected products and contact LivaNova USA Inc. for further instructions.
The recalled product
- Product
- Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 96
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 2003400083
Distribution
Part of a larger recall action
This product is one of 22 recalled by LivaNova 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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