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Terminated

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

FDA Recall Z-0745-2022 · Posted None

Recalling FirmPhysio-Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2022-01-13
Date Terminated2023-05-19
Product Quantity1

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

U.S.: AK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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