Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes
FDA device recall Z-2140-2024 · posted 2024-06-26 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 2,510 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-05-29
- Date posted
- 2024-06-26
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Breathe Technologies Life2000™ Ventilation System (K170037) | Breathe Technologies | 2017-08-11 |