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Ventec Life Systems, Inc.: REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver

Medical DevicesSource: FDA (device) · Date: 2026-09-30

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Ventec Life Systems, Inc.
Product
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Reason / hazard
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Recall initiated
2026-07-28
Code info
UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Bothell
State
WA
Country
United States
Event id
99660
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