Reported Jul 30, 2014 · Terminated

Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated…

Heartsine Technologies, Limited

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, Limited · 203 Airport Road West · Belfast · N/A

Is this the product you have?

  • Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
Lot codes and dates
  • Pad-Pak 01 & Pad-Pak 02 ¿
  • Adult Lot NumbersA1785 to A1805 ¿
  • Pediatric Lot NumbersP433 to P445
Amount recalled
3245

Where it was sold

  • Nationwide

Why it was recalled

A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 16, 2015 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.