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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm January 13, 2022
Create Date March 10, 2022
Recall Status1 Terminated 3 on May 19, 2023
Recall Number Z-0745-2022
Recall Event ID 89536
PMA Number P160008 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Code Information GTIN/UDI: 05060167120695, Serial Number: 20D00009694
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact
425-867-4000
Manufacturer Reason
for Recall		 Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
FDA Determined
Cause 2		 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 in Commerce 1
Distribution U.S.: AK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MKJ and Original Applicant = HeartSine Technologies, Ltd.
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