VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used

FDA device recall Z-1070-2024 · posted 2024-02-23 · Open, Classified

Recall details

Recalling firm

Ventec Life Systems, Inc.

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.

Action taken

On 12/22/2023, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION via Direct overnight mail, or FedEx, or email, or hand delivered, to customers informing them that Ventec Life Systems is recalling a specific lot (listed below) of the VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) since the bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Customer are instructed to: 1. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 2. Stop use of the affected Patient Breathing Package and replace it with a non-affected product. 3. Inspect current stock and quarantine/segregate any unused affected products to prevent their use. For questions/assistance - contact Ventec Life Systems directly at 844-MYVOCSN (844-698-6276), Monday through Friday between 8:00 a.m. - 5:00 p.m. PDT.

Root cause

Process control

Status

Open, Classified

Product code

CBK

Quantity affected

250 breathing circuits

Distribution

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

Date initiated

2024-01-09

Date posted

2024-02-23

Location

Bothell, WA

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