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 and involves a potential breach of the sterile barrier, which poses a risk of infection (risk-of-harm) without reported injuries or illnesses in the source text.
Plain-English summary
LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors (ASY 1/4 X 3/8 Reducer with LL 24). The recall involves 24 units per package, specifically identified by Lot 2003400081. The product is a sterile medical device used in clinical settings.
The firm identified through internal testing that the sterile barrier of these connectors may present a breach. This issue potentially affects components assembled with a specific packaging type and is associated with a specific production period. The recall is classified as Class II by the FDA.
The affected products 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. Additionally, one unit was distributed to Hospital de Barsuto in Bilbao, Spain. Healthcare facilities should stop using the affected lots and contact LivaNova for further instructions.
The recalled product
- Product
- Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
- 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 2003400081
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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