Sterilizable Internal Defibrillation Paddles
Brand(s)
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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