Device recall
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
- Recall number
- Z-3221-2026
- 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
- 21 units
- Code info
- UDI:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG
- Distribution
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Bothell, WA, United States