United StatesWhat's being recalled
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069
Recalling firm: HeartSine Technologies Ltd, Belfast, United Kingdom.
How to identify it
Product - 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers: 24D98056051D24 24D98057467D24 24D98057468D24 24D98057469D24 24D98068091E24 24D98068097E24 24D98070022F24 24D98070023F24 24D98070024F24 24D98070025F24 24D98070026F24 24D98070027F24 24D98070028F24 24D98070029F24 24D98070030F24 24D98070031F24 24D98070032F24 24D98070033F24 24D98070034F24 24D98070035F24 24D98070036F24 24D98070037F24 24D98070038F24 24D98070040F24 24D98070041F24 24D98070042F24 24D98070043F24 24D98070046F24 24D98070047F24 24D98070048F24 24D98070049F24 24D98070050F24 24D98070051F24 24D98070052F24 24D98070053F24 24D98070054F24 24D98070055F24 24D98070056F24 24D98070057F24 24D98070058F24 24D98070060F24 24D98070061F24 24D98070062F24 24D98070063F24 24D98070064F24 24D98070065F24 24D98070066F24 24D98070068F24 24D98070069F24 24D98070071F24 24D98070072F24 24D98070074F24 24D98070075F24 24D98070076F24 24D98070077F24 24D98070078F24 24D98070079F24 24D98070080F24 24D98070081F24 24D98070082F24 24D98070083F24 24D98070084F24 24D98070085F24 24D98070087F24 24D98070088F24 24D98070089F24 24D98070091F24 24D98070092F24 24D98070093F24 24D98070094F24 24D98070095F24 24D98070096F24 24D98070097F24 24D98070100F24 24D98070102F24 24D98070103F24 24D98070104F24 24D98070107F24 24D98070108F24 24D98070109F24 24D98070110F24 24D98070111F24 24D98070114F24 24D98070115F24 24D98070117F24 24D98070118F24 24D98070119F24 24D98070120F24 24D98070121F24 24D98070122F24 24D98070123F24 24D98070126F24 24D98070127F24 24D98070128F24 24D98070129F24 24D98070130F24 24D98070132F24 24D98070133F24 24D98070134F24 24D98070135F24 24D98070136F24 24D98070138F24 24D98070139F24 24D98070140F24 24D98070141F24 24D98070143F24 24D98070144F24 24D98070145F24 24D98070148F24 24D98070149F24 24D98070150F24 24D98070151F24 24D98070157F24 24D98070160F24 24D98070161F24 24D98070162F24 24D98070163F24 24D98070166F24 24D98056785D24 24D98057279D24 24D98057648D24 24D98053900E24 24D98054669E24 24D98054543E24 24D98054034E24…
The hazard
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)