LivaNova USA Sterile Disposable Connector recall
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Why was LivaNova USA Sterile Disposable Connector 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item# EC2135S, Lot No. 1923900091
- Product
- LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
- Recalling firm
- LivaNova USA Inc.
- Quantity
- 140 units
- Distribution
- Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
- Recall date
- July 29, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)