Z-1070-2024Class I

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

Name: Z-1070-2024 VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF...
Creator: Ventec Life Systems, Inc.
Published: 2024-01-09
License: https://open.fda.gov/license/

Ventec Life Systems, Inc. / initiated 2024-01-09 / Open, Classified / root cause: manufacturing process

FDA source

Ventec Life Systems, Inc. began a recall of VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory... on 2024-01-09. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1070-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-01-09
Posted: 2024-02-23
Recalling firm: Ventec Life Systems, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 250 breathing circuits
Distribution: U.S.: CA, CO, FL, HI, IN, MO, NC, and WA O.U.S.: Japan
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1070-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-23

Product code CBK

K162877Class IIVOCSN Unified Respiratory SystemVentec Life Systems, Inc. / cleared 2017-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)