Home / Recalls / Ventec Life Systems, Inc. / Z-1070-2024

Z-1070-2024 Class I Ongoing

Recalled by Ventec Life Systems, Inc. — Bothell, WA

Recall Details

Product Type: Devices
Report Date: March 6, 2024
Initiation Date: January 9, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 250 breathing circuits

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.

Distribution Pattern

U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan

Code Information

Box Label - Part Numbers: PRT-01013-000 Pouch Label - Part Number: PRT-00802-001 UDI-DI Code: 00855573007594 Lot Number: 220922 Pack Slip Lot Number: 257337