United StatesHeartSine samaritan PAD public access defibrillators, models SAM 350P, SAM 360P and SAM 450P (including SAM 350P US Device, US English 2 Min CPR UDI‑DI 0506016712067; 350P US (American Airlines) 0506016712207; 350P US with Gateway 0506016712804; 360P US 0506016712068; 450P US 0506016712069) are affected. The devices were recalled because a damaged (over‑stretched) membrane tail can cause an intermittent fault. The recall was initiated by HeartSine Technologies Ltd and involves 11,912 units distributed worldwide.
What's being recalled
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 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices…
Recalling firm: HeartSine Technologies Ltd, Belfast, United Kingdom.
How to identify it
350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K23 23D98001134L23 23D98001634I23 23D98001722F23 23D98002004K23 23D98002054K23 23D98002059I23 23D98002086L23 23D98002225K23 23D98002639K23 23D98002649K23 23D98002771L23 23D98002897K23 23D98003187A24 23D98003188L23 23D98003198F23 23D98003221K23 23D98003523K23 23D98004710K23 23D98004956L23 23D98005238E23 23D98005242K23 23D98008495L23 23D98008520K23 23D98008591K23 23D98008832K23 23D98008910E23 23D98009571F23 23D98009597F23 23D98009629I23 23D98009835L23 23D98009905F23 23D98010830K23 23D98012539K23 23D98012748G23 23D98013452K23 23D98013684F23 23D98014324L23 23D98014750K23 23D98014988K23 23D98015098K23 23D98015120K23 23D98015207K23 23D98015221K23 23D98015222K23 23D98015231L23 23D98015571F23 23D98016139F23 23D98016168K23 23D98016187F23 23D98016436K23 23D98016463F23 23D98016490L23 23D98016718K23 23D98016725K23 23D98017989L23 23D98018269K23 23D98018271K23 23D98018272J23 23D98018274J23 23D98018277J23 23D98018280K23 23D98018284J23 23D98018285K23 23D98018286J23 23D98018287J23 23D98018290K23 23D98018291K23 23D98018292J23 23D98018294F23 23D98020005K23 23D98023298L23 23D98024058K23 23D98024075K23 23D98100344K23 23D98100567I23 23D98100620L23 23D98100627I23 23D98102225K23 23D98102340K23 23D98102422K23 23D98102666L23 23D98103547K23 23D98103822J23 23D98103971J23 23D98103972K23 23D98103973J23 23D98103974J23 23D98103975J23 23D98103976J23 23D98103977J23 23D98103979J23 23D98103980J23 23D98103981J23 23D98103982J23 23D98103983J23 23D98103984J23 23D98103985J23 23D98103988J23 23D98103989J23 23D98103990J23 23D98103991L23 23D98103992J23 23D98103993J23 23D98103994J23 23D98103995J23 23D98104017L23 23D98104195J23 23D98104196J23 23D98104197K23 23D98104198J23 23D98104199J23 23D98104231J23 23D98104232K23 23D98104234J23 23D98104235J23 23D98104236K23 23D98104237J23 23D98104238J23 23D98104239J23 23D98104240J23 23D98104243J23…
The hazard
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
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
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Indonesia, ISRAEL, JAPAN, Malaysia, Netherlands, Philippines, POLAND, SINGAPORE, South Korea, Taiwan, Thailand and UNITED KINGDOM.
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)