FDA Device recall Z-1070-2024
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001)
- FDA Device
- Class I
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class I recall of VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001) by Ventec Life Systems, citing 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/….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1070-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-01-09 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ventec Life Systems |
| Distribution | CA, CO, FL, HI, IN, MO, NC, WA |
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.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1070-2024%22
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