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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
- Hazard
- Affected units
- 1
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:
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