FDAClass IIJuly 30, 2014

Pad-Pak and Pedi-Pak accessories for the HeartSine recall

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

Why was Pad-Pak and Pedi-Pak accessories for the HeartSine recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.

Product
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode…
Recalling firm
Heartsine Technologies, Limited
Quantity
3245
Distribution
Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
Recall date
July 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls