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B.BRAUN
B.Braun Avitum AG · Model 7210933 · UDI-DI 04046963845780
MMY
Prescription
0
510(k) clearances
42
Adverse events (5 deaths)
2
Recalls
6
Facilities
Description
H.E.L.P. HEPARIN ADSORBER (US)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-17 | Kaneka America Corp | Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhib |
| 2006-07-06 | Wako Chemicals, USA Inc | Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the |
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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.