—#211337

Product

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

FDA product code: CBK — Ventilator, Continuous, Facility Use
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K170037
Affected lot / code info: UDI/DI 00887761978201, Serial Numbers: 124080000663, 124020000164, 124020000165, 124020000166, 124020000167, 124020000168, 124020000169, 124020000170, 124020000171, 124020000172, 124020000173, 124020000174, 124020000175, 124020000176, 124080000659, 124080000661, 124080000662, 124080000666, 124080000667, 124080000668, 124080000669, 123420000499, 123490000931, 124010000910, 124020000163, 124080000670, 124080000672, 124080000673, 124080000675, 124080000677, 124080000678, 124080000679, 124080000715, 124080000716, 124080000718, 124080000733, 124080000735, 124080000772, 124080000784, 124080000854, 124080000855, 124080000856, 124080000857, 124080000863, 124080000865, 124080000919, 124080000920, 124080000921, 124080000922, 124080000923, 124080000924, 124080000925, 124080000926, 124080001290, 124080001367, 124080001388, 124080001409, 124080001594, 124080001596, 124080001601, 124080001602, 124080001603, 124080001604, 124080001605, 124080001606, 124080001608, 124080001609, 124080001610, 124080001612, 124080001614, 124140000062, 124140000063, 124140000065, 124140000067, 124140000068, 124140000069, 124140000070, 124140000123, 124140000125, 124140000126, 124140000127, 124140000401, 124140000402, 124140000403, 124140000404, 124140000405, 124140000636, 124140000637, 124140000638, 124140000668, 124140000671, 124140000672, 124140000675, 124140000677, 124140000679, 124140000681, 124140000683, 124140000684, 124140000686, 124140000687, 124140000688, 124140001005, 124140001014, 124140001187, 124140001191, 124140001195, 124140001201, 124140001203, 124160001584, 124170000747, 124170000749, 124170000804, 124170000828, 124170000832, 124170001158, 124170001159, 124170001161, 124170001162, 124170001163, 124170001166, 124170001171, 124170001172, 124200000070, 124200000071, 124200000072, 124200000073, 124200000074, 124200000076, 124200000077, 124200000078, 124200000079, 124200000080, 124200000081, 124200000083, 124200000084, 124200002473, 124200002474, 124200002475, 124200002476, 124200002478, 124200002479, 124200002480, 124200002481, 124200002482, 124200002485, 124200002486, 124200002489, 124200002490, 124200002491, 124200002492, 124200002493, 124200002494, 124200002495, 124200002496, 124200002497, 124200002498, 124200002499, 124200002500, 124200002501, 124200002502, 124200002503, 124200002504, 124200002505, 124200002506, 124200002507, 124200002508, 124200002509, 124250000491, 124250000492, 124250000493, 124250000494, 124250000495, 124250000496, 124250000497, 124250000498, 124250000499, 124250000500, 124250000533, 124250000534, 124250000535, 124250000536, 124250000537, 124250000538, 124260000558, 124260001171, 124280000585, 124280000741.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US, Nationwide Distribution

Timeline

Recall initiated: 2024-12-20
Posted by FDA: 2025-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211337. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.