Device 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.
Z-1928-2020
Product summary
- Event
- Event 85409
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35
- Official record key
device-enforcement:Z-1928-2020
Official wording
Reason: Intermittent communication due to inconsistent crimping of connectors onto cables.
Code information: 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.
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.
Derived failure modes
-
Unknown
Intermittent communication due to inconsistent crimping of connectors onto cables.