Z-1928-2020 Class II Terminated
FDA device recall Z-1928-2020 was initiated by Edwards Lifesciences, LLC on October 7, 2019 and is designated Class II. Reason for recall: Intermittent communication due to inconsistent crimping of connectors onto cables. The recall status is terminated (terminated April 27, 2021). Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- October 7, 2019
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Product Description
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 for Recall
Intermittent communication due to inconsistent crimping of connectors onto cables.
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.
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.