Device recalls

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, ClassifiedProcess controlZ-3222-2026
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.