HeartSine Technologies Ltd: 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

Is my product affected?

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

• UPC 0506016712067
• UPC 0506016712207
• UPC 0506016712804

Check against the official notice below — it lists the full affected range.

Hazard

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

Details from the source

Reason for recall: Due to a damaged (over stretched) membrane tail that causes an intermittent fault. Distribution: 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, Ta Quantity: 11,912 Lot/code info: 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 23D98103975J

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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