Recall Z-1070-2024 ยท CBK Ventilator, Continuous, Facility Use
Ventec Life Systems, Inc.
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
| Date | Feb 23, 2024 (initiated Jan 9, 2024) |
| Status | Open, Classified |
| Reason | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients. |
| Root cause | Process control |
| Action | On 12/22/2023, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION via Direct overnight mail, or FedEx, or email, or hand delivered, to customers informing them that Ventec Life Systems is recalling a specific lot (listed below) of the VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) since the bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Customer are instructed to: 1. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 2. Stop use of the affected Pa |
| Quantity | 250 breathing circuits |
| Distribution | U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162877 | VOCSN Unified Respiratory System Ventec Life Systems, Inc., Apr 7, 2017 |