CanadaInfant/Child Reduced Energy Defibrillation Electrode by Physio‑Control, Inc. (model/catalogue numbers 11101‑000016 and 11101‑000017) with lot/serial numbers 315303, 315639, 315858, 316007, 318931 and 320529 is affected. On November 21, 2024 Stryker began investigating product complaints of gel delamination of the pediatric electrodes; contact the manufacturer for additional information.
What's being recalled
Companies: Physio-Control, Inc., 11811 Willows Road North East, Redmond, Washington, United States, 98052.
How to identify it
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 318931; Model or catalogue number: 11101-000016
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 315639; Model or catalogue number: 11101-000016
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 315303; Model or catalogue number: 11101-000016
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 316007; Model or catalogue number: 11101-000016
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 320529; Model or catalogue number: 11101-000016
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 315858; Model or catalogue number: 11101-000016
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 318931; Model or catalogue number: 11101-000017
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 315639; Model or catalogue number: 11101-000017
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 315303; Model or catalogue number: 11101-000017
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 316007; Model or catalogue number: 11101-000017
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 320529; Model or catalogue number: 11101-000017
Affected products: Infant/Child Reduced Energy Defibrillation Electrode; Lot or serial number: 315858; Model or catalogue number: 11101-000017
The hazard
On November 21, 2024 Stryker began investigating product complaints related to the gel delamination of pediatric electrodes.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States