Recall Z-1070-2024— Ventec Life Systems, Inc.

Name: FDA recall Z-1070-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-09

Class I · Ongoing

Class I FDA medical device recall by Ventec Life Systems, Inc., initiated 2024-01-09. It names one FDA 510(k) clearance: K162877. Product: 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.. 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..

Recalling firm: Ventec Life Systems, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-01-09
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K162877 — VOCSN Unified Respiratory SystemVentec Life Systems, Inc.·cleared 2017-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.