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VOCSN Patient Breathing Package recallZ-1070-2024 · Ventec Life Systems, Inc. · initiated Jan 9, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ventec Life Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1070-2024
Status
Open, Classified
Initiated by the company
Jan 9, 2024
Posted by the FDA
Feb 23, 2024
Recalling firm
Ventec Life Systems, Inc.
Quantity
250 breathing circuits
Product code
CBK
FDA submissions
K162877
Distribution
U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

22 devices cleared under K162877 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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