PRA number
2021/18957
Published date
Product description
LIFEPAK CR2 defibrillators are automated external defibrillators (AEDs) used in cases of life-threatening irregular heartbeat that leads to Sudden Cardiac Arrest (SCA)
ARTG 282772 (Stryker Australia Pty Ltd - Non-rechargeable public automated external defibrillator)
ARTG 282772 (Stryker Australia Pty Ltd - Non-rechargeable public automated external defibrillator)
Reasons the product is recalled
The LIFEPAK CR2's lid magnet may dislodge from the device. The lid magnet is the primary means by which the device will turn on and off when the lid is opened or closed. If the battery dislodges:
1. The battery may be depleted prematurely, even if the device is not powered on; and
2. Users may not be able to turn the device on if they do not use the on/off button or if the battery has fully depleted.
1. The battery may be depleted prematurely, even if the device is not powered on; and
2. Users may not be able to turn the device on if they do not use the on/off button or if the battery has fully depleted.
The hazards to consumers
If the battery has been depleted or users do not turn the device on, the device will not work and will not be available to defibrillate a patient in an emergency.
What consumers should do
Stryker is contacting all customers to provide Supplemental Instructions and replacement accessories, where needed.
Affected consumers are advised to perform the following for all LIFEPAK CR2 Defibrillators:
1. Inspect the defibrillator and record the item and serial number of the device on the customer response form.
2. Review and retain the Supplemental Instructions attached to the customer letter.
3. Inspect the lid for the presence of a magnet as per the instructions in the customer letter.
4. Conduct a Device Readiness check in accordance with the LIFEPAK CR2 Operating Instructions, maintaining a State of Readiness (pp. 77-78), and the Supplemental Instructions provided with the customer letter.
5. Return the customer response form to Stryker or a distributor, indicating the results of these inspections and checks.
If consumers have a device which does not turn on when the lid is opened, they can continue to use it by using its power button to turn it on and off and follow the updated operating instructions.
For further information, consumers can contact the Stryker Post Market Team on postmarketssp@stryker.com or 0427 540 168.
Affected consumers are advised to perform the following for all LIFEPAK CR2 Defibrillators:
1. Inspect the defibrillator and record the item and serial number of the device on the customer response form.
2. Review and retain the Supplemental Instructions attached to the customer letter.
3. Inspect the lid for the presence of a magnet as per the instructions in the customer letter.
4. Conduct a Device Readiness check in accordance with the LIFEPAK CR2 Operating Instructions, maintaining a State of Readiness (pp. 77-78), and the Supplemental Instructions provided with the customer letter.
5. Return the customer response form to Stryker or a distributor, indicating the results of these inspections and checks.
If consumers have a device which does not turn on when the lid is opened, they can continue to use it by using its power button to turn it on and off and follow the updated operating instructions.
For further information, consumers can contact the Stryker Post Market Team on postmarketssp@stryker.com or 0427 540 168.
Supplier
Stryker Australia Pty Ltd
Traders who sold this product
Authorised Stryker distributors
Where the product was sold
Nationally
International
Dates available for sale
-
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.