Z-2750-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- June 26, 2018
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 in total
Product Description
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
Reason for Recall
H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip Test Failure which disables the H/Sat module.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, SC, TN, TX, WA, and WV. Foreign distribution to Middle East, Latin America, Europe, Japan, Canada, and Mexico.
Code Information
H011684 H011685 H011686 H011687 H011688 H011689 H011691 H011692 H011693 H011694 H011695 H011696 H011697 H011699 H011700 H011701 H011702 H011704 H011705 H011706 H011707 H011708 H011709 H011710 H011711 H011712 H011713 H011714 H011715 H011717 H011718 H011719 H011721 H011722 H011723 H011725 H011726 H011727 H011730 H011731 H011732 H011733 H011735 H011736 H011737 H011738 H011742 H011744 H011745 H011747 H011749 H011750 H011751 H011752 H011753 H011754 H011755 H011756 H011757 H011758 H011759 H011760 H011761 H011762 H011766 H011772 H011778 H011779 H011780 H011781 H011783 H011784 H011785 H011786 H011788 H011789 H011790 H011791 H011792 H011793 H011794 H011795 H011796 H011797 H011798 H011799 H011800 H011801 H011803 H011804 H011805 H011806 H011807 H011808 H011809 H011810 H011811 H011812 H011813 H011814 H011815 H011817 H011819 H011821 H024598 H024599 H024600 H024601 H024602 H024603 H024604 H024605 H024606 H024607 H024608 H024611 H024612 H024613 H024614 H024615 H024616 H024617 H024618 H024620 H024621 H024624 H024625 H024626 H024627 H024628 H024629 H024631 H024632 H024633 H024635 H024636 H024637 H024638 H024639 H024641 H024642 H024643 H024645 H024647 H024649 H024652 H024654 H024655 H024657 H024659 H024674