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
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 potential breach of the sterile barrier in a medical device, which poses a risk of harm (infection) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
LivaNova USA Inc. is recalling 48 units of Sterile Disposable Connectors (ASY STR CONN 3/16 STRLE 24) under recall number Z-2446-2020. The recall is limited to Lot 2004300003. The firm identified through internal tests that the sterile barrier of these 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 products were distributed to facilities in 38 U.S. states and the District of Columbia, as well as to a hospital in Spain. The specific states listed include 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.
Healthcare facilities should stop using the affected connectors and contact LivaNova USA Inc. for further instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 48
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 2004300003
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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