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HeartSine Samaritan PAD 450P recallZ-0745-2022 · Physio-Control, Inc. · initiated Jan 13, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Physio-Control, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0745-2022
Status
Terminated
Initiated by the company
Jan 13, 2022
Recalling firm
Physio-Control, Inc.
Quantity
1
Product code
MKJ
FDA submissions
P160008
Distribution
U.S.: AK

Product description

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

Code information (models, lots, serial numbers)

GTIN/UDI: 05060167120695, Serial Number: 20D00009694

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

15 devices cleared under P160008 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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