Z-3221-2026 Class II Ongoing
FDA device recall Z-3221-2026 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: 21 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
- 21 units
Product Description
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
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:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG