VOCSN Patient Breathing Package — Class I medical device recall Z-1070-2024
Ongoing recall by Ventec Life Systems, Inc., reported 2024-03-06, distributed in CA, CO, FL, HI, IN, MO, NC, WA. The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the
| Recall number | Z-1070-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventec Life Systems, Inc., Bothell, WA, United States |
| Recall initiated | 2024-01-09 |
| Classified | 2024-02-23 |
| Reported by FDA | 2024-03-06 |
| Distributed | CA, CO, FL, HI, IN, MO, NC, WA |
| Countries outside the US | JP |
| Quantity | 250 breathing |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00855573007594 |
| Lot numbers | 220922, 257337 |
| Model numbers | PRT-00802-001, PRT-01013-000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1070-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.