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.
FDA Recall Z-2115-2014 · Posted 2014-07-24
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Recalling FirmHeartsine Technologies, Limited
Recall StatusTerminated
Product CodeMKJ
Date Initiated2014-06-12
Date Terminated2015-04-16
Product Quantity3245
Reason for Recall
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
Firm 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 information.
For question contact Quality Manager at +44 (0)28 90 93 94 19.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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