Ventec Life Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1070-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: January 9, 2024

Date Posted: March 6, 2024

Recall Number: Z-1070-2024

Event ID: 93806

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.

Status: Ongoing

Product Quantity: 250 breathing circuits

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated