Product Discontinuation Notice
1 Page
Preview
Page 1
October 30, 2020
PRODUCT DISCONTINUATION NOTICE Dear Valued Stryker Customer,
This is a follow up to a previous communication from April 2019 to confirm that Stryker is ending support for the LIFEPAK® 12 monitor/defibrillator, LIFEPAK 20 defibrillator/monitor (separate device from our PMA approved LIFEPAK 20e defibrillator/monitor), and LIFEPAK 500 defibrillator in the United States. Discontinuation notices have been sent for both devices and accessories over the last few years, as maintaining parts and service on aging devices becomes increasingly complex and challenging. Due to the COVID-19 pandemic, the FDA has extended the deadline to cease the distribution of supporting accessories for nonPMA devices from February 3, 2021 to February 3, 2022. “Manufacturers of legacy AEDs are expected to communicate the extension date with customers and continue to facilitate customer transition from any legacy AED to an FDA-approved AED as appropriate.” Based on previous guidance from FDA in April 2019, Stryker had taken steps to discontinue affected devices and accessories. Stryker is no longer able to extend support for these devices and will continue with discontinuation plans previously communicated. Discontinuation dates for LIFEPAK 12/500/20:
We honored existing service contracts for LIFEPAK 12 through June 30, 2020. Accessories that are part of some service plans, including LIFEPAK 500 and LIFEPAK 12 batteries, were discontinued as of February 3, 2020. Other accessories such as pad electrodes, that are universal to PMA approved devices still on the market, will continue to be available and will no longer be marketed for these non-PMA devices after February 3, 2022. LIFEPAK 20 batteries and service will be available as supplies last, but no later than December 31, 2020. Stryker offers a range of devices for your needs that are PMA-approved and available in the US. •
•
•
•
The LIFEPAK 15 monitor/defibrillator, the latest version of which was launched in 2014, supports EMS and hospital customers around the world and sets the standard for durability and ease of use while offering the advanced University of Glasgow 12-lead algorithm and escalating energy up to 360J for difficult-to-defibrillate patients.
The LIFEPAK 20e defibrillator/monitor is designed specifically for crash carts and in-hospital patient transport, offering 360J escalating biphasic energy for both manual and automatic defibrillation. An optional module provides advanced monitoring and facilitates CPR effectiveness.
The LIFEPAK 1000 defibrillator combines the simplicity of an AED, including onscreen and audio prompts with the flexibility of manual mode operation when indicated. Flexible setup options allow on-screen graphics for the basic rescuer or ECG display and access to manual mode for the more advanced rescuer. The LIFEPAK 1000 provides powerful defibrillation, long battery life, and LIFEPAK TOUGH™ durability that can stand up to severe environments.
The LIFEPAK CR2 defibrillator, which was launched in the US in February 2019, is our next generation LIFEPAK AED, featuring Wi-Fi® connectivity, cprINSIGHT™ analysis technology (which enables the defibrillator to analyze the patient’s heart rhythm while CPR is being performed), a Child Mode button and Optional Language button.
We thank you for your business and continued partnership. We are committed to providing high-quality, clinically supported products so that you can be confident in the care you are providing to your communities. Please contact your local Stryker sales representative or authorized distributor to discuss trade-up and flexible financing options to support you during this transition. Chris Walsh
Director, Marketing
Copyright © 2020 Stryker. GDR 3344238_B
Emergency Care 11811 Willows Road NE, Redmond, WA 98052 USA | P +1 425 867 4000 | Toll-free +1 800 442 1142 | stryker.com