Class 2 Device Recall CooperSurgical Oxygen Sensor

• Date Initiated by Firm: June 30, 2021
• Create Date: August 16, 2021
• Recall Status: Terminated on November 21, 2022
• Recall Number: Z-2307-2021
• Recall Event ID: 88277
• Product Classification: Incubator, neonatal - Product Code FMZ
• Product: 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].
• Code Information: Serial Numbers: 531540 531541 531542 531543 531544 531545 531546 531547 531548 531549 531550 531551 531552 531553 531554 531555 531556 531557 531558 531559 531560 531561 531562 531563 531564 531565 531566 531567 531568 531569 531570 531571 531572 531573 531574 531575 531576 531577 531578 531579 531580 531581 531582 531583 531584 531585 531586 531587 531588 531589 531590 531591 531597 531598 531599 531600 531601 531602 531603 531604 531605 531606 531607 531608 531609 531610 531611 531612 531613 531614 531615 531616 531617 531618 531619 531620 531621 531622 531623 531624 531625 531626 531627 531628 531629 531630 531631 531632 531633 531634 531635 531636 531637 531638 531639 531640 531641 531642 531643 531644 531645 531646 531647 531648 531649 531650 531651 531652 531653 531654 531655 531656 531657 531658 531659 531660 531661 531662 531663 531664 531665 531667 531668 531669 531670 531671 531672 531673 531674 531675 531676 531677 531678 531679 531690 531691 531692 531693 531694 531695 531696 531697 531698 531699 531700 531701 531702 531703 531704 531705 531706 531707 531708 531709 531710 531711 531712 531713 531714 531715 531716 531717 531718 531719 531721 531722 531723 531724 531725 531726 531727 531728 531729 531730 531731 531732 531733 531734 531735 531736 531737 531738 531739 531740 531741 531742 531743 531744 531745 531746 531747 531748 531749 532001 532034 532035 532036 532037 532038 532039 532040 532041 532042 532043 532044 532045 532046 532047 532048 532052 532053 532054 532070 532071 532072 532073 532074 532075 532076 532077 532079 532080 532081 532082 532083 532084 532085 532086 532087 532088 532089 532090 532091 532092 532103 532104 532105 532106 532107 532108 532109 532110 532111 532112 532113 532114 532115 532116 532117 532118 532119 532120 532121 532122 532123 532124 532125 532126 532127 532128 532129 532130 532131 532132 532134 532135 532136 532137 532138 532139 532140 532141 532142 532143 532144 532145 532146 532147 532148 532149 532150 532151 532152 540659 540660 540661 540662 540663 540665 540666 540667 540668 540669 540670 540671 540672 540673 540674 540675 540676 540677 540678 540679 540680 540681 540682 540683 540684 540685 540686 540687 540688 540689 540691 540692 540693 540694 540695 540696 540697 540698 540699 540700 540701 540702 540708 540710 540711 540712 540713 540714 540715 540716 540717 540718 540719 540720 540721 540723 540724 540725 540726 540727 540730 540731 540732 540733 540734 540735 540736 540737 540738 540739 540740 540741 540742 540743 540744 540745 540746 540747 560830 560831 560900 560901 560930 560952 560953 560954 560967 560968 560969 560970 560971 560972 560973 560974 560975 560976 560977 560978 560979 560980 560981 560983 560984 560985 560986 560987 560988 560989 560990 560991 560992 560993 560994 560995 560996 560997 560998 561000 561001 561002 561003 561004 561005 561006 561007 561008 561009 561010 561011 561012 561019 561025 561026 561027 561028 561030 561031 561032 561033 561034 561035 561036 561040 582528 582531 582533 582534
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Customer Service; 203-601-9818
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Vendor change control
• 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.
• Quantity in Commerce: 421 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.