FDA Device recall Z-2642-2020
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
- FDA Device
- Class III
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class III recall of LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case by Livanova Usa, citing 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 ea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2642-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-11-18 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | KS, MN, MO, UT, WA |
Product
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
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.
Identifiers
| code_info | Item# EC2135S, Lot No. 1923900091 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2642-2020%22
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