The Recall Desk
LowFDA (Devices)·Z-0745-2022·Announced 2022-03-16

HeartSine Samaritan PAD Defibrillator Shipped Without Battery and Pads

Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or deaths. The issue is missing components (incomplete shipment/fulfillment) rather than a defective device, consistent with packaging-only problems.

Plain-English summary

Physio-Control, Inc. is recalling HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators that were shipped without battery and electrode packs. At least one unit (serial number 20D00009694) was distributed in Alaska.

These devices are non-functional without the battery and electrode pads, which are critical components needed to operate the defibrillator in emergency situations.

If you received a HeartSine Samaritan PAD defibrillator without battery and electrode packs, contact Physio-Control immediately for the missing components. Do not attempt to use the device until it is fully equipped.

The recalled product

Product
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Manufacturer
Physio-Control, Inc.
Category
Medical Device — Defibrillator / AED
Hazard
  • missing-components

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • GTIN/UDI: 05060167120695
  • Serial Number: 20D00009694

Distribution

Distributed in 1 state:

  • AK

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