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.
Recall
- Recall Number
- Z-2115-2014
- Event Number
- 68703
- Firm
- Heartsine Technologies, Limited 203 Airport Road West Belfast United Kingdom
- FEI Number
- 3004123209
- Product Code
- MKJ
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- June 12, 2014
- Posted
- July 24, 2014
- Terminated
- April 16, 2015
Description
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.
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
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 information. For question contact Quality Manager at +44 (0)28 90 93 94 19.
Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
3245