FDA Medical Device Recalls (openFDA)
Physio-Control, Inc.: HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
- Recall number
- Z-0745-2022
- Recalling firm
- Physio-Control, Inc.
- Product
- HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
- Status
- Terminated
- Initiated
- 2022-01-13
- Posted
- not on file
- Terminated
- 2023-05-19
- Reason
- Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
- 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 medtechsup@stryker.com if they had questions or concerns.
- Quantity
- 1
- Distribution
- U.S.: AK
- Lot, serial or model codes
- GTIN/UDI: 05060167120695, Serial Number: 20D00009694
- 510(k) numbers
- not on file
- PMA numbers
- ["P160008"]
- Product code
- MKJ
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28