Product Recall Notice

From Stryker - Urgent Field Safety Notice: RA2023-3293631 If you have any of the affected products, please get in touch with us and we will assist you. Product description The Pad-Pak is a single use battery and electrode cartridge containing the battery to power the HeartSine samaritan PAD (LiMnO2 (18V – 1500mAh) non-rechargeable battery) and two electrode pads to provide the electrical connection for delivery of defibrillation to the patient’s chest. Product Issue Stryker is conducting a voluntary recall as we have determined that the affected PadPaks may be rendered inoperable due to depleted battery cells. As a result, the affected Pad-Paks could potentially fail to power on the device if needed for use. Potential Risks The issue could prevent device from analysing patient  condition or delivering therapy correctly. To date, there have been no reports of adverse events.

Affected Products

GTIN Product Description Lot Numbers

N/A 360-BAS-UK-10 350-BAS-UK-10 350-BAS-AS-10 350-BAS-CF-10 350-BAS-CN-10 350-BAS-JA-08 350-BAS-KO-10 350-BAS-MS-10 350-BAS-USROW-10 360-BAS-AS-10 360-BAS-CN-10 360-BAS-KO-10 360-BAS-SJ-10 360-BAS-JA-08 450-BAS-JA-08 500-BAS-JA-08 500-BAS-AS-10 500-BAS-CF-10 500-BAS-CN-10 500-BAS-KO-10 500-BAS-TH-10 500-BAS-UK-10 PAD-PAK-01 PAD-PAK-03 PAD-PAK-03j

A3632 A3633 A3634 A3635 A3636 A3637 A3638 A3639 A3640 A3641 A3642 A3643 A3644 A3652 A3653 A3654 A3655 A3656 A3657 A3658 A3659 A3660 A3661 A3662 A3663 A3664 A3665 A3666 A3667 A3668 A3669 A3672 A3678 A3681 A3682 A3764 A3765 A3766 A3770 A3772 A3773 A3774 A3775 A3776 A3777 A3778 A3779 A3780 A3781 A3782 A3783 A3784 A3785 A3786 A3787 A3788 A3799 A3800 A3801 A3802 A3803 A3804 A3805 A3807 A3821 A3829 A3832 A3833 A3834 A3840 A3842 A3843 A3844 A3845 A3846 A3847 A3848 A3849 J0748 J0749 J0750 J0751 J0752 J0753 J0754 J0755 J0756 J0758 J0759 J0760 J0761 J0786 J0787 J0788 J0789 J0790 J0791 J0792 J0793 J0794 J0795 J0796 J0797 J0798 J0799 J0801 J0802

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