Z-1070-2024 Class I Ongoing
FDA device recall Z-1070-2024 was initiated by Ventec Life Systems, Inc. on January 9, 2024 and is designated Class I. 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 resul… The recall status is ongoing. Affected quantity: 250 breathing circuits.
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