Class 1 Device Recall Welch Allyn, Inc., Life 2000

• Date Initiated by Firm: December 20, 2024
• Date Posted: January 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0885-2025
• Recall Event ID: 95842
• 510(K)Number: K170037
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
• Code Information: UDI/DI 00887761981638, Serial Numbers: L1903102-017, L1911019-025, L2001042-007, L2001042-016, L2003015-264, L2005055-916, L2006020-163, L2006020-265, L2006020-455, L2006020-499, L2006020-548, L2007003-009, 120190000085, 120190000090, 120190000707, 120190000713, 120190000714, 120190000730, 120210000714, 120210000719, 120210000740, 120210000744, 120210000756, 120210000759, 120210000760, 120210000884, 120210001610, 120270001439, 120270001446, 120270001452, 120270001453, 120270001455, 120270001469, 120270001478, 120280000212, 120280000218, 120280000241, 120280000248, 120280000341, 120280000347, 120280000349, 120280000354, 120280000356, 120280000360, 120280000364, 120280000368, 120280000369, 120280000376, 120280000380, 120280000850, 120280000851, 120280000864, 120280000873, 120280000880, 120280000975, 120280000977, 120280000978, 120280000979, 120280000989, 120290000531, 120290000536, 120290000550, 120290000607, 120290000615, 120290000629, 120290000630, 120290000650, 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• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer 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.
• FDA Determined 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: 946 units
• Distribution: US, Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK