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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential breach of a sterile barrier in a medical device represents a significant risk of infection, aligning with the Severe criteria for Class II recalls.
Plain-English summary
LivaNova USA Inc. is recalling 984 units of Sterile Disposable Connectors (ASY Y CONN 3/8 X 3/8 X 3/8) due to a potential breach in the sterile barrier. The firm identified this issue through internal tests, noting that the problem affects components assembled with specific packaging during a specific production period.
The affected products are identified by Lot numbers 2002800191 and 2003400085. These units were distributed to facilities in 40 U.S. states and the District of Columbia, as well as to a hospital in Spain. The recall is classified as Class II by the FDA.
Healthcare facilities should stop using the affected connectors and contact LivaNova USA Inc. for further instructions on the recall process.
The recalled product
- Product
- Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 984
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 2002800191
- 2003400085
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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