Recall Z-1928-2020 ยท DQK Computer, Diagnostic, Programmable
Edwards Lifesciences, LLC
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.
| Date | May 8, 2020 (initiated Oct 7, 2019) |
| Status | Terminated |
| Reason | Intermittent communication due to inconsistent crimping of connectors onto cables. |
| Root cause | Process control |
| Action | On xx/xx/2019, and URGENT MEDICAL DEVICE RECALL-ACTION REQUIRED, letter was sent to customers by FedEx. Customers are instructed to acknowledge this notification , contact the firm at the contact information in the communication to obtain a Returned Goods Authorization (RGA) number and to return all product to recalling firm. |
| Quantity | 35 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable Edwards Lifesciences, LLC, Apr 14, 2017 |