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U.S. Department of Health and Human Services

Class 2 Device Recall PadPak and PediPak accessories for the HeartSine SamaritanPAD 300P and 350P device

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  Class 2 Device Recall PadPak and PediPak accessories for the HeartSine SamaritanPAD 300P and 350P device see related information
Date Initiated by Firm June 12, 2014
Date Posted July 24, 2014
Recall Status1 Terminated 3 on April 16, 2015
Recall Number Z-2115-2014
Recall Event ID 68703
510(K)Number K052465  K123881  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 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.
Code Information Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.
Recalling Firm/
Manufacturer		 Heartsine Technologies, Limited
203 Airport Road West
Belfast United Kingdom
Manufacturer 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.
FDA Determined
Cause 2		 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 information. For question contact Quality Manager at +44 (0)28 90 93 94 19.
Quantity in Commerce 3245
Distribution Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = HEARTSINE TECHNOLOGIES, INC.
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