Class 1 Device Recall Life2000 Ventilator

• Date Initiated by Firm: May 29, 2024
• Date Posted: June 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2140-2024
• Recall Event ID: 94701
• 510(K)Number: K170037
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
• Code Information: Life2000 Ventilator: UDI Number: 00887761978089; Product Code: MS-01-0118. Life2000 Ventilator System: a. Product Code: BT-20-0002; Serial Numbers: 123300001188, 123300001189, 123300001190, 123300001191, 123300001192, 123300001193, 123300001194, 123300001195, 123300001196, 123300001197, 123300001220, 123300001221, 123300001222, 123300001223, 123300001224, 123300001225, 123300001227, 123300001292, 123300001293, 123300001416, 123300001418, 123300001419, 123300001420, 123300001421, 123300001423, 123300001424, 123300001425, 123300001426, 123300001428, 123300001612, 123300001614, 123300001615, 123300001616, 123300001617, 123300001618, 123300001619, 123300001620, 123300001621, 123300001669, 123300001670, 123300001671, 123300001672, 123300001673, 123300001674, 123300001675, 123300001676, 123300001677, 123300001678, 123300001683, 123300001684, 123300001685, 123300001688, 123300001689, 123300001690, 123300001691, 123300001769, 123300001770, 123300001771, 123300001772, 123300001773, 123300001774, 123300001775, 123300001776, 123300001778, 123300001779, 123300001780, 123300001781, 123300001782, 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Product Code: BT-20-0002AP, Serial Number: 120380001667
• 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: Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
• FDA Determined Cause: Under Investigation by firm
• Action: Baxter Healthcare began notifying consignees on about 05/29/2024 via " URGENT MEDICAL DEVICE RECALL" letter sent U.S.P.S first class mail. Patients, healthcare providers, wholesalers and distributors were instructed to ensure patients always have an alternate means of ventilator or oxygen therapy available, inspect the battery charger dongle for damage and replace immediately if damaged, and patients may continue to use the ventilator system once they inspect and confirm no damage to the dongle and battery is charging appropriately. Patients were also asked to observe any alarms of the ventilator system and notify Baxter Home Care Customer Service for any assistance, that Baxter will replace their ventilator device upon their next scheduled in-home visit with a clinical trainer, and to acknowledge receipt of the letter. Healthcare providers, wholesalers and distributors were requested to observe any alarms of the ventilator system and notify Baxter Acute Care Customer Service Support, 800-426-4224, option 2, between the hours of 8:00am and 5:00pm Central Time, Monday through Friday, for any assistance, arrange for the return of any impacted product and to acknowledge receipt of the letter. Additionally, they were asked to notify customers if further distributed. For general questions regarding this Medical Device Recall, Baxter Acute Care Customer Service Support at 800-426-4224, option 2, or Baxter Clinical Support at 800 397 9071.
• Quantity in Commerce: 2,510 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