BEUDAMED
    FDA Recall Terminated

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    Recall: Z-2307-2021 · Initiated June 30, 2021

    Recall

    Recall Number
    Z-2307-2021
    Event Number
    88277
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    June 30, 2021
    Terminated
    November 21, 2022
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    Reason

    Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.

    Action

    CooperSurgical notified affected affected Regionals and Countries and through the Sales Managers to Affected Consignees by Urgent Field Safety Notice Oxygen Sensors letter via email on 6/30/21. Letter states reason for recall, health risk and action to take: If the affected product at your facility is displaying any of the above characteristics, please complete the attached Acknowledgement and Receipt Form to arrange for an onsite field service call at CooperSurgicals expense. Otherwise, this issue will be addressed at your next onsite routine service at no expense for the correction. Please be advised that we are expecting the Oxygen Sensor replacement to be approximately an extra 2.5 hours during this service. If you do not have affected Oxygen Sensors in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Field Safety Notice. Please feel free to reach us at +001.203.601.5200 ext. 3300 with any questions regarding this notice.

    Distribution

    Only Foreign: Bahrain, Belgium, Bulgaria, Czech Republic Denmark, Egypt, Estonia, France, Georgia, Germany, Ghana, Great Britain, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates and Vietnam.

    Quantity

    421 units