Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2457-2020 — Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382

U.S. FDA — Device Enforcement · United States · 2020-04-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2457-2020
Date of alert
2020-04-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
LivaNova USA Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2003400088
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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