LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 744 units 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 involves a medical device where the sterile barrier may be breached, posing a risk of harm (infection) even though no injuries have been reported yet, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
LivaNova USA Inc. is recalling 744 units of Sterile Disposable Connectors (ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306). The recall is limited to Lot 2002800190. The firm identified through internal tests that the sterile barrier of these specific connectors may present a breach. The issue potentially affects components assembled with a specific packaging and is associated with a specific production period.
The affected units were distributed to facilities in the United States (including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV) and to Hospital de Barsuto in Bilbao, Spain.
Healthcare facilities should stop using the affected connectors and contact LivaNova USA Inc. for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 744
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 2002800190
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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