Recall archive / FDA device enforcement
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak — FDA record Z-0745-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
- Reason
- Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
- Classification
- Class III
- Recalling firm
- Physio-Control, Inc.
- Quantity
- 1
- Agency-reported status
- Terminated
- Source record identifier
- Z-0745-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN/UDI: 05060167120695, Serial Number: 20D00009694 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AK
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 16, 2022
- Recall initiation date
- Jan 13, 2022
- Center classification date
- Mar 10, 2022
- Termination date
- May 19, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.