FDAApril 26, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

heartsine technologiesheartsine

UPCs

050601671226060506016712141805060167121371050601671247470506016712159305060167124525050601671215170506016712080005060167121630050601671225140506016712575105060167122712

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear