Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68703

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 12, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Heartsine Technologies, Limited

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2115-2014
Recall number
Z-2115-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
3245

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.

Distribution pattern

Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.