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Recall Observatory FDA recall evidence

Device product

LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

Z-2642-2020

November 18, 2019

Class III

Product summary

Firm
LivaNova USA Inc.
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

    reason.no_named_rule · v1.0.0

    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.