Reported Jul 8, 2020 · Terminated
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
LivaNova USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova USA Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- 1/4X3/8 REDUC CONN
- STRL REF/ GTIN for Insert LabelEC2140S/ 00803622129315
- Lot codes and dates
LOT 20049000162002800193
- Amount recalled
- 420 units
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Where it was sold
Why it was recalled
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
This product could cause temporary or reversible health problems — stop using it.
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