{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Belfast",
      "state": "N/A",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92346",
      "recalling_firm": "HeartSine Technologies Ltd",
      "address_1": "207 Airport Road West",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN,\tMO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA,\tVT,\tWA & WI and OUS (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy,\tJapan, Korea, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Thailand, & United Kingdom.",
      "recall_number": "Z-2143-2023",
      "product_description": "HeartSine, REF:  PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and  with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P",
      "product_quantity": "30,022 units",
      "reason_for_recall": "Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.",
      "recall_initiation_date": "20230426",
      "center_classification_date": "20230713",
      "report_date": "20230719",
      "code_info": "Model #/UDI-DI #: 360-BAS-UK-10/05060167122606, 350-BAS-UK-10/05060167121418, 350-BAS-AS-10/05060167121371, 350-BAS-CF-10/05060167124747, 350-BAS-CN-10/05060167121593, 350-BAS-JA-08/05060167124525, 350-BAS-KO-10/05060167121517, 350-BAS-MS-10/05060167120800, 350-BAS-USROW-10/05060167121630, 360-BAS-AS-10/05060167122514, 360-BAS-CN-10/05060167125751, 360-BAS-KO-10/05060167122712, 360-BAS-SJ-10/05060167128028, 450-BAS-JA-08/05060167127663, 500-BAS-AS-10/05060167125812, 500-BAS-CF-10/05060167125836, 500-BAS-CN-10/05060167125843, 500-BAS-KO-10/05060167126444, 500-BAS-TH-10/05060167125997, 500-BAS-UK-10/05060167122453, PAD-PAK-01/05060167120466,PAD-PAK-03/05060167121234,PAD-PAK-03j/05060167124754   Models/Lot #   360-BAS-UK-10/ A3659, A3655, A3664, A3654, A3803, A3829, A3840, A3842, A3848,  A3840, A3843, A3842, A3844, A3842, J0754, J0754, J0755,  J0752, J0798;  350-BAS-UK-10/ A3664, A3799, A3803, A3829,A3840,A3846, J0753, J0753, J0754, J0756;  350-BAS-AS-10/ A3656; 350-BAS-CF-10/ A3635, A3805, J0801;  350-BAS-CN-10/ A3633, A3636, A3805, A3833, J0801; 350-BAS-JA-08/ A3779  A3783, A3780, A3783, J0758, J0758;  350-BAS-KO-10/ J0753;  350-BAS-MS-10/ J0753; 350-BAS-USROW-10/ A3644; 360-BAS-AS-10/ A3656; 360-BAS-CN-10/ A3635; 360-BAS-KO-10/A3660 A3646, A3665, J0753, J0754;  360-BAS-SJ-10/ A3660; 450-BAS-JA-08/ A3779, A3783, A3788, A3821; 500-BAS-AS-10/ A3656; 500-BAS-CF-10/ A3635; 500-BAS-CN-10/ A3632, A3635, A3634, A3681; 500-BAS-KO-10/ A3660; 500-BAS-TH-10/ J0754, J0755, J0754; 500-BAS-UK-10/ A3654, A3654, A3664, A3664, A3765, A3787, A3801, A3840, J0753, J0755, J0754, J0756, J0748, J0798;   PAD-PAK-01/ A3632 A3633 A3634 A3635 A3636 A3637 A3642 A3656  A3657 A3657 A3657  A3662 A3669 A3681 A3678 A3682 A3766, A3777 A3778 A3781 A3782 A3805 A3807 A3833 A3833 A3834 A3834  A3832 A3840 J0759 J0761  J0760;  PAD-PAK-03/ A3638  A3639 A3640  A3658  A3644  A3644 A3655  A3666  A3653 A3652 A3641  A3643  A3660  A3664  A3665  A3672 A3663 A3668 A3667 A3661 A3659  A3764 A3765 A3770  A3772  A3773  A3774 A3775 A3776 A3779  A3784  A3785  A3786 A3787  A3787 A3785  A3799  A3799 A3800  A3801  A3802 A3802  A3803 A3804  A3829 A3829  A3840  A3845  A3846  A3847  A3849  A3849 A3845 J0749  J0749 J0748  J0750  J0751  J0752  J0753 J0753  J0754  J0756  J0786  J0786  J0790  J0791  J0787 J0788  J0788  J0789 J0792 J0792  J0795 J0794 J0793 J0792  J0796  J0797  J0798  J0799;  PAD-PAK-03j/ A3788 and A3821",
      "more_code_info": ""
    }
  ]
}