Recall Z-1445-2023 ยท BTC Bag, Reservoir
Draeger Medical, Inc.
VentStar breathing bag Set (P) 110, MP00384
| Date | May 17, 2023 (initiated Apr 17, 2023) |
| Status | Terminated |
| Reason | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
| Root cause | Process control |
| Action | The firm distributed recall notifications to consignees via FedEx starting on 4/17/2023. Consignees are instructed to immediately stop use of affected devices, inspect current stock, and quarantine any affected devices to prevent use. Alternative therapy for patients should be instituted as soon as possible and ensure all users of affected devices within consignee organizations are aware of the recall, with copies being forwarded if devices were further distributed. To replace or return unused products, consignees are to call Draeger Customer Success between 8:00 AM - 6:00 PM EST, Monday thru |
| Quantity | 25 units |
| Distribution | Domestic: US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.