LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 20 units of Sterile Standalone Connectors because internal tests identified 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 sterile barrier breach in a medical device, which poses a risk of harm (infection) but the source text does not report any specific injuries or illnesses, 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 20 units of Sterile Standalone Connectors (1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278). The recall involves Lot 2004900015. The firm identified through internal tests that the sterile barrier of these specific 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 in the United States to Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. One unit was also distributed to Hospital de Barsuto in Bilbao, Spain.
Consumers and healthcare facilities should stop using the affected Sterile Standalone Connectors and contact LivaNova USA Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 20
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 2004900015
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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