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Sol-Cart B®

B. BRAUN MEDICAL INC. · Model 839 · UDI-DI 04046955634828

KPO Prescription
10
510(k) clearances
30,009
Adverse events (23,081 deaths)
109
Recalls
34
Facilities

Description

SOLCART B USA SOD.BIC.-CARTR. 760GR

Recalls

DateFirmReason
2026-07-14Fresenius Medical Care Renal Therapies Group, LLCComplaints of blue-green discoloration in product
2026-07-14Fresenius Medical Care Renal Therapies Group, LLCComplaints of blue-green discoloration in product
2026-07-14Fresenius Medical Care Renal Therapies Group, LLCComplaints of blue-green discoloration in product
2026-05-12Fresenius Medical Care Holdings, Inc.Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-
2026-05-07Fresenius Medical Care Holdings, Inc.There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the pro
2025-11-05Diasol, IncSafety and efficacy of dialysis acid concentrate cannot be assured
2025-11-05Diasol, IncSafety and efficacy of dialysis acid concentrate cannot be assured
2025-11-05Diasol, IncSafety and efficacy of dialysis acid concentrate cannot be assured
2025-11-05Diasol, IncSafety and efficacy of dialysis acid concentrate cannot be assured
2025-11-05Diasol, IncSafety and efficacy of dialysis acid concentrate cannot be assured

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Data 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.