Ventec Life Systems, Inc.: 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 provi

Hazard

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.

Details from the source

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 Quantity: 250 breathing circuits Lot/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

UPC codes

00855573007594

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.