DeviceSignal · Recall classified
Fresenius Medical Care Renal Therapies Group, LLC
FDA classified a device recall on 2026-09-02 · Class II · Z-3085-2026
EventRecall classified
Effective2026-09-02
ClassificationClass II
On 2026-09-02 the FDA classified a device recall from Fresenius Medical Care Renal Therapies Group, LLC as Class II. Product: 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3. Recall Z-3085-2026. The firm initiated it on 2026-08-10. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3085-2026
- Classification
- Class II
- Classified on
- 2026-09-02
- Initiated on
- 2026-08-10
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Reason
- Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Product
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3085-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
a15a03c25f9aa749d59cdc9472adf794d7448ad79e596c590f55a5079e06ff00- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)