Recall Z-2115-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Heartsine Technologies, Limited
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.
| Date | Jul 24, 2014 (initiated Jun 12, 2014) |
| Status | Terminated |
| Reason | A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. |
| Root cause | Packaging process control |
| Action | HeartSine notified distributors in the United States by e-mail on June 12, 2014 and by follow-up letter on June 13, 2014. Distributors were given a letter to use in communications with customers on June 17, 2014. Customers were instructed to return affected product to there distributors. Distributors were asked to return the affected product to HeartSine. In order to effect an immediate return, replacement Pad-Paks and Pedi-Paks have already been delivered to all respective distributors. A seconde letter, dated June 30th, was sent to end users to clarify where on the label to find lot specific |
| Quantity | 3245 |
| Distribution | Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America. |
| FDA record | Open on fda.gov |