LivaNova Recalls Sterile Connectors Due to Potential Barrier Breach
LivaNova USA Inc. is recalling 600 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a breach in the sterile barrier of a medical device, which poses a significant risk of infection.
Plain-English summary
LivaNova USA Inc. is recalling 600 units of Sterile Disposable Connectors (ASY CONN REDUCER 3/8 X 1/4) due to a potential breach in the sterile barrier. The issue was identified through internal tests and affects components assembled with a specific packaging during a specific production period.
The recalled product is associated with Lot 2003400082. The distribution pattern includes 41 U.S. states and the District of Columbia, as well as one hospital in Spain. The agency has classified this recall as Class II.
Consumers and healthcare facilities should stop using the affected sterile connectors and contact LivaNova USA Inc. for further instructions or a replacement.
The recalled product
- Product
- Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 600
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 2003400082
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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