Device product
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Z-2642-2020
Product summary
- Event
- Event 85858
- Status
- Terminated
- Classification
- Class III
- Quantity
- 140 units
- Official record key
device-enforcement:Z-2642-2020
Official wording
Reason: 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.
Code information: Item# EC2135S, Lot No. 1923900091
Distribution pattern: Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
Derived failure modes
-
Unknown
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.