Baxter is recalling the Life2000 Air flow System attributable to a cybersecurity problem found by way of inside testing, the FDA studies.
The Life2000 Air flow System is meant to supply steady or intermittent respiratory help for individuals who require mechanical air flow help. Particularly, the system is used for grownup sufferers who require optimistic strain air flow delivered by way of an endotracheal tube or a masks. The system contains each the Life2000 Ventilator and the Life2000 Compressor.
In keeping with the FDA, if an unauthorized individual had been to realize bodily entry to an unattended gadget, they might probably change gadget remedy settings or entry gadget information. This may occasionally result in the life-supporting air supply perform not working as supposed.
Use of the affected product might trigger critical antagonistic well being penalties, together with accidents brought on by gadget malfunction or full failure of important respiratory help and dying, in accordance with the FDA.
As of April 10, 2025, Baxter has reported no critical accidents or deaths related to this problem, the FDA says.
Affected Product
- Product Title: Life2000 Air flow System
| Product Code | UDI-DI Quantity | Product Code on Delivery Carton | Product Description | Serial Numbers |
|---|---|---|---|---|
| MS-01-0100 | 00815410020278 | BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT200007, BT-20-0011, BT200011, and RMS010118CP | Life2000 Ventilator |
All |
| MS-01-0118 | 00887761978089 or 00815410020537 |
BT-20-0002, BT-20-0002A, BT-20-0002AP, BT-20-0007, BT200007, BT-20-0011, BT200011, and RMS010118CP | Life2000 Ventilator |
All |
| MS-01-0093 | 00887761978072 or 00815410020292 |
BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP | Life2000 Compressor |
All |
| MS-01-0121 | 00887761978041 | BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP | Life2000 Compressor |
All |
| MS-01-0125 | 00887761976283 | BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP | Life2000 Compressor |
All |
FDA Suggestions
Cease utilizing Life2000 ventilators. Sufferers ought to attain out to their healthcare supplier to debate alternative choices. Don’t depart ventilators unattended in public or unsecured areas.
On April 10, 2025, Baxter despatched all affected prospects an Pressing Medical Machine Recall letter recommending the next actions:
- For residence sufferers:
- Attain out to your healthcare supplier to debate remedy alternative choices and switch care to an alternate medical gear provider.
- As soon as various remedy and medical gear suppliers have been recognized, contact Baxter Superior Respiratory, Inc, House Care Buyer Service at 800-426-4224 choice 3, to rearrange for the everlasting return of the Life2000 Air flow System.
- Don’t depart Life2000 Air flow Methods unattended in public or unsecured areas. Sustaining bodily possession and management of the ventilator reduces the chance of an unauthorized individual getting access to the gadget.
- For those who suspect your gadget has been uncovered to an unauthorized individual, contact your healthcare crew after which contact Baxter Superior Respiratory House Care Buyer Service to confirm the gadget settings are appropriate and that the gadget is performing as anticipated.
- If communication got here from Baxter, acknowledge receipt by following directions on the Affected person Reply Instruction Sheet that was enclosed with the letter.
- For sufferers who acquired communication by way of one other medical gear provider (aside from Baxter), reply to your provider in accordance with their directions. Any questions on a provider’s communication must be despatched to that provider.
- For all healthcare-related prospects (well being care services, DME suppliers, and distributors):
- Find and discontinue use of all Life2000 ventilators and compressors throughout the facility.
- Don’t depart Life2000 Air flow System unattended in public or unsecured areas. Sustaining bodily possession and management of the ventilator reduces the chance of an unauthorized individual getting access to the gadget.
- For those who suspect {that a} gadget has been uncovered to unauthorized personnel, contact Baxter Acute Care Buyer Service crew. The crew might help confirm whether or not the gadget settings are appropriate and if the gadget is performing as anticipated. The crew might be reached by e mail at [email protected], or by telephone at 800-426-4224, choice 2, then choice 1.
- Ahead this communication to any departments throughout the establishment who use the affected product.
- For DME suppliers:
- Notify sufferers utilizing Life2000 ventilators of this recall.
- Work with sufferers and prescribers to establish an alternate remedy choice.
- For distributors:
- Disseminate this info and conduct a user-level recall of the affected product distributed to prospects.
Baxter will proceed to supply alternative chargers for individuals who expertise a battery charger failure associated to the earlier correction, Baxter Healthcare Company Points Correction for Life2000 Ventilator As a result of a Nonconforming Battery Charger [02/05/2025], till all Life2000 ventilators are faraway from use. Nevertheless, the agency won’t replace affected gadgets associated to the prior correction, Baxter Healthcare Updates Use Directions for Life2000 Air flow System As a result of Threat of No Low Gasoline Stress Alarm [10/24/2024].
Contact Data
Clients within the U.S. with questions on this recall ought to contact:
- House care prospects and/or sufferers: House Care Buyer Service crew at 800-426-4224, choice 3, or Baxter Scientific Assist at 800-397-9071.
- Healthcare suppliers, DME suppliers, and distributors: Baxter Acute Care Buyer Service crew at 800-426-4224, choice 2, then choice 1
