Z-0886-2025Class I

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Name: Z-0886-2025 Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Creator: Baxter Healthcare Corporation
Published: 2024-12-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-12-20 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP on 2024-12-20. FDA classified it as Class I and gives the reason as "There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0886-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-20
Posted: 2025-01-16
Recalling firm: Baxter Healthcare Corporation
Product: Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/20/2024 via USPS first class mail. The notice explained the problem with the device, hazard involved, and requested the following actions be taken: 1. Always have an alternate means of ventilation or oxygen therapy available. 2. Patients may continue using the Life2000 ventilator if it is functioning correctly. If the ventilator becomes inoperable, place the patient on an alternate means of ventilation, if necessary, and contact Baxter Advanced Respiratory, Clinical Support team at 800-397-9071. 3. In the interim if patients experience this failure and have an additional charger available, connect it to the ventilator and verify that the ventilator is charging. 4. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. 6. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to the Director of Respiratory Therapy, Patient Safety, and any other departments within your institution who use the affected product. 7. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. Durable Medical Equipment providers are required to notify patients of this Urgent Medical Device Correction by forwarding the attached home patient letter. For general questions regarding this Urgent Medical Device Correction, please contact the Baxter Advanced Respiratory team at 800
Quantity in commerce: 1 unit
Distribution: US, Nationwide Distribution
Product codes and lots: UDI/DI 00887761981638, Serial Numbers: 122010001081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0886-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0884-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16
Z-0885-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16
Z-0886-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16
Z-0887-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code CBK

K170037Class IIBreathe Technologies Life2000™ Ventilation SystemBreathe Technologies / cleared 2017-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)