Z-3222-2026 Class II Ongoing
FDA device recall Z-3222-2026 was initiated by Ventec Life Systems, Inc. on Jul 28, 2026 and is designated Class II. Reason for recall: Labeling; Oxygen Cylinders do not contain required medical gas labeling The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Jul 28, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Reason for Recall
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Distribution Pattern
US Nationwide distribution in the states of FL, IA, OH, NE, TN.
Code Information
UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM