Reported Apr 2, 2025 · Ongoing
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of…
Calyxo, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Calyxo, Inc. · 4473 Willow Rd · Pleasanton, CA · 94588-8571
Is this the product you have?
- CVAC Aspiration System
- REFCVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior
- Lot codes and dates
- CVC127020-1 UDI-DI
00860005357710L00018 Rev C
- CVC127020-1 UDI-DI
- Amount recalled
- 11,246
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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