FDAFebruary 19, 2025device
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.
What to do
FDA enforcement status: Ongoing
Brands named
calyxo
UPCs
00860005357710
Recall history
No related federal recalls on record for this brand yet.
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