Z-0745-2022Class III

HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

Name: Z-0745-2022 HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Creator: Physio-Control, Inc.
Published: 2022-01-13
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2022-01-13 / Terminated / root cause: manufacturing process

FDA source

Physio-Control, Inc. began a recall of HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak on 2022-01-13. FDA classified it as Class III and gives the reason as "Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0745-2022
Classification: Class III
Status: Terminated
Initiated: 2022-01-13
Posted: 2022-03-10
Terminated: 2023-05-19
Recalling firm: Physio Control, Inc.
Product: HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 01/13/2022, Stryker telephoned the customer and informed them of the correction. The telephone call was followed up with a correction notice, mailed to the customer on 01/17/22, that informed the customer to contact Customer Service at 1 800 787 9537, option 2, 8:00 A.M. to 7:00 P.M. (Eastern Time), Monday - Friday or by email at [email protected] if they had questions or concerns.
Quantity in commerce: 1
Distribution: U.S.: AK
Product codes and lots: GTIN/UDI: 05060167120695, Serial Number: 20D00009694

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0745-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0745-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-10

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)