LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors because internal tests identified a potential breach 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 sterile barrier breach, which poses a risk of harm (infection) but no injuries or illnesses have been reported in the source text.
Plain-English summary
LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors (3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292). The recall is associated with Lot 2004300009 and specific production periods.
The firm identified through internal tests that the sterile barrier of these connectors may present a breach. This issue potentially affects components assembled with a specific packaging configuration. The affected units were distributed to various U.S. states and one hospital in 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
- 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 860
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 2004300009
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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