5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw 03-5150-2Recalls & reported problems
Fresenius Medical Care Renal Therapies Group, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 29, 2025Class IIOpen, Classified
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Z-1992-2025 · Root cause: Process control · Recall details · FDA record ↗
Other Accessories, Blood Circuit, Hemodialysis devices
- CombiSet Twister 03-2794-0Fresenius Medical Care Holdings, Inc. · ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS1 death91 reports
- Crit-Line® CL10041021Fresenius Usa, Inc. · ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS69 reports
- 5008X HDF Hemodialysis Blood Tubing Set 03-5100-7Fresenius Medical Care Renal Therapies Group, LLC · Accessories, Blood Circuit, Hemodialysis1 recall10 reports
- 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber 03-5100-7CFresenius Medical Care Renal Therapies Group, LLC · Accessories, Blood Circuit, Hemodialysis1 recall0 reports
- Crit-Line® CL10041001Fresenius Medical Care Holdings, Inc. · ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS26 reports
- Crit-Line® 191058Fresenius Usa, Inc. · ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS8 reports
- CombiSet SMARTECH 03-2722-9CFresenius Medical Care Renal Therapies Group, LLC · Accessories, Blood Circuit, Hemodialysis5 reports
- Crit-Line® CL10051001Fresenius Medical Care Holdings, Inc. · ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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