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.
FDA Recall Z-1928-2020 · Posted 2020-05-08
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Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDQK
Date Initiated2019-10-07
Date Terminated2021-04-27
Product Quantity35
Reason for Recall
Intermittent communication due to inconsistent crimping of connectors onto cables.
Firm 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.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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