Z-2115-2014Class II

Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P)...

Name: Z-2115-2014 Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P)...
Creator: Heartsine Technologies, Limited
Published: 2014-06-12
License: https://open.fda.gov/license/

HeartSine Technologies Ltd / initiated 2014-06-12 / Terminated / root cause: packaging

FDA source

Heartsine Technologies, Limited began a recall of Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies... on 2014-06-12. FDA classified it as Class II and gives the reason as "A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2115-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-12
Posted: 2014-07-24
Terminated: 2015-04-16
Recalling firm: HeartSine Technologies Ltd
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: packaging
FDA 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 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.
Product codes and lots: Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2115-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2115-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-24

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)