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Diacap®
B.Braun Avitum AG · Model 7107367 · UDI-DI 04039239090496
FKQ
Prescription
10
510(k) clearances
19
Adverse events (4 deaths)
2
Recalls
6
Facilities
Description
Diacap® Ultra Dialysis Fluid Filters
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-20 | Medivators, Inc. | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
| 2013-03-01 | B. Braun Medical, Inc. | There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration c |
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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.