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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:128482

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.

Official recall number

Z-2115-2014

Evidence summary

Product code
MKJ
Recall status
Terminated
Event initiated
June 12, 2014
Root cause
Packaging process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2115-2014