Home › Fresenius Usa, Inc. › Crit-Line®
Crit-Line®
Fresenius Usa, Inc. · Model 191058 · UDI-DI 00840861102020
KOC
Prescription
1
510(k) clearances
1,220
Adverse events (17 deaths)
17
Recalls
49
Facilities
Description
Blood Chamber II
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-10 | Fresenius Medical Care Renal Therapies Group, LLC | 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 hypovol |
| 2026-08-10 | Fresenius Medical Care Renal Therapies Group, LLC | 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 hypovol |
| 2026-08-10 | Fresenius Medical Care Renal Therapies Group, LLC | 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 hypovol |
| 2026-08-10 | Fresenius Medical Care Renal Therapies Group, LLC | 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 hypovol |
| 2018-09-06 | Stihler Electronic Gmbh | PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn |
| 2018-09-06 | Stihler Electronic Gmbh | PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn |
| 2018-09-06 | Stihler Electronic Gmbh | PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn |
| 2016-05-24 | Fresenius Medical Care Renal Therapies Group, LLC | Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop. |
| 2015-04-27 | Fresenius Medical Care Holdings, Inc. | Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber |
| 2015-01-20 | Molded Products Inc | A customer relayed a complaint of a leaking dialysis tubing connector. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.