Reported Jul 29, 2020 · Terminated
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
LivaNova USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
LivaNova USA Sterile Disposable Connector1/2x1/220 units per case
- Lot codes and dates
Item# EC2135SLot No. 1923900091
- Amount recalled
- 140 units
Where it was sold
Why it was recalled
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 is expected as the issue is easily detectable and the different shape would prevent use of the connector.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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