LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling specific lots 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 is classified as FDA Class II. The hazard involves a potential breach in the sterile barrier of 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 USA Inc. is recalling specific lots of Sterile Disposable Connectors (ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290). The recall involves 24 units per package, specifically Lot 2003400084.
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 products were distributed in the United States and Spain.
No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 24
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 2003400084
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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