Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2115-2014 — 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 electro

U.S. FDA — Device Enforcement · United Kingdom · 2014-06-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2115-2014
Date of alert: 2014-06-12
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Heartsine Technologies, Limited
Product category: device
Product type: Devices

Reported risk: A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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