Reported Jul 19, 2023 · Ongoing
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public…
HeartSine Technologies Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HeartSine Technologies Ltd · 207 Airport Road West · Belfast, N/A · N/A
Is this the product you have?
- HeartSine
- REFPAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan
- Public Access Defibrillator models350P/360P/450P/500P
- Lot codes and dates
22 of 22 products · 66 lot codes
Recalled lot codes, grouped by product number Product number Lot codes and dates 350-BAS-UK-10A3664A3799A3803A3829A3840A3846J0753J0753J0754J0756
350-BAS-AS-10A3656
350-BAS-CF-10A3635A3805J0801
350-BAS-CN-10A3633A3636A3805A3833J0801
350-BAS-JA-08A3779 A3783A3780A3783J0758J0758
350-BAS-KO-10J0753
350-BAS-MS-10J0753
350-BAS-USROW-10A3644
360-BAS-AS-10A3656
360-BAS-CN-10A3635
- Amount recalled
- 30,022 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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