LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach
LivaNova USA Inc. is recalling 120 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.
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 risk-of-harm product (sterile barrier breach) where no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
LivaNova USA Inc. is recalling 120 units of Sterile Disposable Connectors (ASY CONN Y 1/2X1/2X3/8 STR 24) due to a potential breach in the sterile barrier. The recall affects Lot 2002800185, which was distributed to facilities in 40 U.S. states and one hospital in Spain.
The firm identified the issue through internal tests, which indicated that the sterile barrier of certain connectors assembled with a specific packaging during a specific production period may present a breach. This defect could compromise the sterility of the medical device.
Healthcare facilities and consumers should stop using the affected connectors and contact LivaNova USA Inc. for further instructions or a replacement.
The recalled product
- Product
- Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 120
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 2002800185
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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