Recall Z-1954-2018 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
| Date | Apr 26, 2018 |
| Status | Terminated |
| Reason | The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices. |
| Root cause | Employee error |
| Action | On April 27, 2018, the recalling firm contacted its consignees by telephone prior to sending out Urgent Medical Device Recall notifications via e-mail. Customers were instructed to remove affected devices from operation immediately. The firm provided replacement devices so customers could send their affected ventilator to the firm's repair center for update once the required parts were available. Customers were also asked to inform all affected users at each site. If you have any questions regarding this letter please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-80 |
| Quantity | 8 units |
| Distribution | Distributed to the states of CT, IL, MN, NV, SD, and WA. |
| 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 |