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RenovaRP

GI Supply, Inc. · Model GIS-31 · UDI-DI 00893029002236

LRO

510(k) clearances

21,411

Adverse events (2 deaths)

1,077

Recalls

159

Facilities

Description

The Laborie RenovaRP® Centesis Kit is intended to be used in conjunction with the RenovaRP Pump, the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Kit is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

Recalls

Date	Firm	Reason
2026-08-18	Cardinal Health 200, LLC	The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl
2026-08-11	Medline Industries, LP	The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu
2026-08-10	AVID Medical, Inc.	Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10	AVID Medical, Inc.	Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
2026-08-10	AVID Medical, Inc.	Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10	AVID Medical, Inc.	Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10	AVID Medical, Inc.	Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10	Medline Industries, LP	Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as
2026-08-10	AVID Medical, Inc.	Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10	Medline Industries, LP	The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r

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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.