Device recall
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
- Recall number
- Z-3223-2026
- Event id
- 99660
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Ventec Life Systems, Inc.
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Jul 28, 2026
- Center classification date
- Sep 18, 2026
- Product code
- ECX
- Device type
- Cylinder, Compressed Gas, And Valve
- Reason
- Labeling; Oxygen Cylinders do not contain required medical gas labeling
- Root cause
- Process control
- Quantity
- 25 units
- Code info
- UDI:00850018761376/ Serial #s: 25EKMA00BAC 25EKMA009L3 25EKMA009CM 25EKMA009J8 25GKMA00077 25GKMA0007B 25GKMA0009Z 25GKMA0004U 25GKMA000CS 25GKMA000CR 25GKMA000CX 25GKMA000D0 25GKMA000LL 25GKMA000N1 25GKMA000UD 25GKMA000D1 25GKMA000TN 25GKMA000D2 25GKMA000UC 25GKMA000LK 25GKMA000UA 25GKMA000UB 25GKMA000UE 25GKMA000CY 25GKMA000UF
- Distribution
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Bothell, WA, United States