FDA recall Z-0745-2022

Physio-Control, Inc. · Class III · device

Product

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

Reason for recall

Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

Distribution

U.S.: AK

Key facts

Status
Terminated
Initiation date
2022-01-13
Report date
2022-03-16
Termination date
2023-05-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0745-2022