FDA Device recall Z-1928-2020
Oxymetry Cable, Rxonly
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of Oxymetry Cable, Rxonly by Edwards Lifesciences, citing intermittent communication due to inconsistent crimping of connectors onto cables.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1928-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-07 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Reason
Intermittent communication due to inconsistent crimping of connectors onto cables.
Identifiers
| code_info | The cables with the following serial numbers (35) are recalled: 13710131, 13710130, 13710129, 13710115, 13710113, 13710…The cables with the following serial numbers (35) are recalled: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1928-2020%22
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