# FDA recall Z-1070-2024

> **Ventec Life Systems, Inc.** · Class I · device recall initiated 2024-01-09.

## 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 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

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

## Key facts

- **Recall number:** Z-1070-2024
- **Recalling firm:** Ventec Life Systems, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-09
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1070-2024

## Citation

> AI Analytics. FDA recall Z-1070-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1070-2024. Source: US FDA. Licensed CC0.

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