LivaNova Recalls 220 Units of 3/8 Inch Y Connectors
LivaNova USA Inc. is voluntarily recalling 220 units of 3/8 inch Y connectors due to a Class II defect.
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, which typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, placing this in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LivaNova USA Inc. is voluntarily recalling 220 units of 3/8X3/8X3/8 Y Connectors (Style Reference EC2105S). The recall was initiated on April 24, 2020, and the FDA classified the event as Class II. The specific reason for the recall is not detailed in the provided source text.
The affected products were distributed to 45 US states, the District of Columbia, and one hospital in Spain. The recall status is currently terminated as of February 17, 2022. No specific injuries, illnesses, or deaths are reported in the source text.
Healthcare facilities and consumers should check their inventory for this specific product and lot number (LOT2004300008). If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the recall has been terminated.
The recalled product
- Product
- 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
- Manufacturer
- LivaNova USA Inc.
- Hazard
- Affected units
- 220
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)
- LOT2004300008
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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