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Recall Observatory FDA recall evidence

Device product

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

Z-0745-2022

January 13, 2022

Class III

Product summary

Firm
Physio-Control, Inc.
Event
Event 89536
Status
Terminated
Classification
Class III
Quantity
1
Official record key
device-enforcement:Z-0745-2022

Official wording

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

Code information: GTIN/UDI: 05060167120695, Serial Number: 20D00009694

Distribution pattern: U.S.: AK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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