LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.
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 risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors (ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351). The recall is limited to Lot 2003400086.
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 various U.S. states and to Hospital de Barsuto in Bilbao, Spain. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
- Manufacturer
- LivaNova USA Inc.
- Hazard
- Affected units
- 768
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 2003400086
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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