LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 420 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, which poses a risk of infection, but the source text does not report any illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
LivaNova USA Inc. is recalling 420 units of 1/4X3/8 Reduc Conn, Sterl Ref (GTIN 00803622129315) due to a potential breach in the sterile barrier. The firm identified this issue through internal tests, noting that the defect may affect components assembled with specific packaging during a specific production period.
The affected lots are 2004900016 and 2002800193. These products were distributed to facilities in 40 U.S. states and the District of Columbia, as well as to Hospital de Barsuto in Bilbao, Spain.
Healthcare facilities should stop using the affected connectors and contact LivaNova USA Inc. for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 420
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 (2)
- LOT 2004900016
- 2002800193
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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