REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Ventec Life Systems, Inc. · Labeling; Oxygen Cylinders do not contain required medical gas labeling
Open FDA's page for this record- Cfres ID
- 222116
- Product res number
- Z-3222-2026
- Event date initiated
- 2026-07-28
- Event date posted
- 2026-09-18
- Recall status
- Open, Classified
- Res event number
- 99660
- Product code
- ECX
- Product description
- REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
- Code info
- UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM
- Firm FEI number
- 3013095415
- Recalling firm
- Ventec Life Systems, Inc.
- Address 1
- 22002 26th Ave Se
- City
- Bothell
- State
- WA
- Postal code
- 98021-4903
- Additional info contact
- George Koos 1-863-2266285
- Reason for recall
- Labeling; Oxygen Cylinders do not contain required medical gas labeling
- Root cause description
- Process control
- Product quantity
- 2 units
- Distribution pattern
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
- Action
On July 28, 2026, Ventec Life Systems Inc. issued a Urgent: Medical Device Recall notification to affected consignees via: certified mail. Ventec ask consignees to take the following actions: 1. Immediately discontinue use of affected HomeFill Oxygen Cylinders. 2. Inspect current stock, quarantine/segregate any unused affected products, remove affected product from clinical service and segregate to prevent further use until the enclosed label correction has been completed. 3. Use an unaffected oxygen cylinder for patient support. 4. If you have distributed or transferred affected product to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification. 5.. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to React Health WITHIN 7 DAYS OF RECEIPT. 6. Upon receipt of the Customer Response Form, React Health will arrange for shipment of the label and instructions to apply the label to affected cylinders along with an update confirmation letter. 7. Update the affected product and return the completed confirmation letter to React Health. Contact Customer Support at 863-226 -6285 to discuss completing the form, if necessary.
- Harmonized identifiers (openFDA)
- Device name
- Cylinder, Compressed Gas, And Valve
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.2700
- Device class
- 1
- K number
- K053117, K062300, K143060, K142149, K161472, K161179, K771246, K132778, K033897, K153518, K131386, K063354, K101792
- Registration number
- 3008281139, 3013530901, 3005621729, 3034694958, 3008115001, 3023339109, 1937613, 3014810929, 2183615, 3003764448, 3020188747, 9613416, 3005380088, 3012311599, 3013846070, 3012002722, 3008791328
- FEI number
- 3008281139, 3013530901, 3005621729, 3034694958, 3001655525, 3008115001, 3023339109, 1937613, 3014810929, 2183615, 3003764448, 3020188747, 3005380088, 3012311599, 3013846070, 3012002722, 3008791328
