HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Summary
The FDA issued a Class III for HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pa by Physio-Control, Inc.. Reason: Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs..
Details
Source
Device Recall
External ID
Z-0745-2022
Action Date
2022-03-16
Status
Terminated
Category
device
Product Description
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Lot/Code Info: GTIN/UDI: 05060167120695, Serial Number: 20D00009694
Quantity Affected: 1
Reason for Recall
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
Distribution
U.S.: AK
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-13
Company
Redmond, WA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Physio-Control, Inc. has 24 FDA actions in our database, including 22 recalls and 2 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Physio-Control, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Physio-Control, Inc. have FDA actions?
Physio-Control, Inc. has 24 FDA actions in our database, including 22 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0745-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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