LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Reported: July 29, 2020 Initiated: November 18, 2019 #Z-2642-2020
Product Description
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Reason for Recall
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.
Details
- Recalling Firm
- LivaNova USA Inc.
- Units Affected
- 140 units
- Distribution
- Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
- Location
- Arvada, CO
Frequently Asked Questions
What product was recalled? ▼
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case. Recalled by LivaNova USA Inc.. Units affected: 140 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2020. Severity: Low. Recall number: Z-2642-2020.
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