Recall archive
7 recalls · page 1 of 1
Reported Jul 29, 2020
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.LivaNova USA Inc.
Matched: Brand · Product · Product details — Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health…
FDA (openFDA device enforcement)
Reported Jul 8, 2020
Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova USA Inc.
Matched: Brand — The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue…
21 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 25, 2020
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova USA Inc.
Matched: Brand · Product · Product details — The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM…
FDA (openFDA device enforcement)
Reported Mar 4, 2020
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.LivaNova USA Inc.
Matched: Brand · Product · Product details — Perfusion tubing pack was packaged with the incorrect cuvette.
FDA (openFDA device enforcement)
Reported Feb 19, 2020
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.LivaNova USA Inc.
Matched: Brand · Product · Product details — Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production…
FDA (openFDA device enforcement)
Reported Nov 6, 2019
SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova USA Inc.
Matched: Brand · Product details — The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the…
FDA (openFDA device enforcement)
Reported Apr 17, 2019
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LivaNova USA Inc.
Matched: Brand — For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
FDA (openFDA device enforcement)
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