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.
Recall
- Recall Number
- Z-2140-2024
- Event Number
- 94701
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- CBK
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 29, 2024
- Posted
- June 26, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
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.
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.
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.
US Nationwide distribution.
2,510 units