VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used
Summary
The FDA issued a Class I for VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013- by Ventec Life Systems, Inc.. Reason: The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural .
Details
Source
Device Recall
External ID
Z-1070-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
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.
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
Quantity Affected: 250 breathing circuits
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-09
Company
Bothell, WA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ventec Life Systems, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ventec Life Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ventec Life Systems, Inc. have FDA actions?
Ventec Life Systems, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1070-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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