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.
This recall has been terminated (originally issued May 8, 2020).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- October 7, 2019
- Posted
- May 8, 2020
- Terminated
- April 27, 2021
- Recall Number
- Z-1928-2020
- Quantity
- 35
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Intermittent communication due to inconsistent crimping of connectors onto cables.
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.