Recall Z-2248-2023 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Carina Sub-Acute Care Ventilator
| Date | Aug 18, 2023 (initiated Jul 12, 2023) |
| Status | Open, Classified |
| Reason | Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Drager, sent an "Urgent Medical Device Recall" to customers by mail on 07/12/2023. The medical device recall notification instructs customers on how to utilize the Carina Ventilator until units can be corrected in the field by way of replacement of the blower to remove the presence of PE-PUR foam. Customers may continue to use the device until it has been modified provided that the set minute volume exceeds 3.6 l/min, only adult patients are ventilated, and only a Draeger ventilation hose with leak valve is used. The firm states that a new designed blower cover will be available in t |
| Quantity | 11,621 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072885 | CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 Draeger Medical AG & Co. KG, Apr 7, 2008 |