Health product recall

Sterilizable Internal Defibrillation Paddles

Last updated

Summary

Product
Sterilizable Internal Defibrillation Paddles
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Sterilizable Internal Defibrillation Paddles

99649025

11131-000044

Sterilizable Internal Defibrillation Paddles

107124605
101506304

11131-000043
11131-000046

Sterilizable Internal Defibrillation Paddles

106917875
96496376
107445069
107078533
107556560
107445059

11131-000045
11131-000047
11131-000042

Issue

Stryker has received complaints indicating issues with the internal paddles. Complaints which state that the paddles are not reaching the expected cleaning and sterilization cycle count designated in the instructions for use and are showing signs of cracking. A CAPA was opened November 2023.

Recall start date: September 20, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Physio-Control, Inc.
11811 Willows Road North East, Redmond, Washington, United States, 98052
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76244

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