LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 240 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.
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 breach of the sterile barrier in a medical device, which poses a risk of harm (infection) but has no reported illnesses or injuries in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LivaNova USA Inc. is recalling 240 units of Sterile Disposable Connectors (ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382). The recall involves Lot 2003400088. The firm identified through internal tests that the sterile barrier of these connectors may present a breach.
The issue potentially affects components assembled with a specific packaging and is associated with a specific production period. The affected units were distributed to facilities in 42 U.S. states and the District of Columbia, as well as to a hospital in Spain.
No specific instructions for consumers or healthcare providers are provided in the source text. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 240
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 2003400088
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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