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Recall Observatory FDA recall evidence

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

October 07, 2019

Class II

Product summary

Firm
Edwards Lifesciences, LLC
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

    reason.no_named_rule · v1.0.0

    Intermittent communication due to inconsistent crimping of connectors onto cables.