HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Ventec Life Systems, Inc. · Labeling; Oxygen Cylinders do not contain required medical gas labeling
Open FDA's page for this record- Cfres ID
- 222115
- Product res number
- Z-3221-2026
- 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
- HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
- 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
- 21 units
- Distribution pattern
- US Nationwide distribution in the states of FL, IA, OH, NE, TN.
- 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
- 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
