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RenovaRP

GI Supply, Inc. · Model GIS-32 · UDI-DI 00893029002175

LRO

510(k) clearances

21,411

Adverse events (2 deaths)

1,059

Recalls

158

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
2026-07-29	Cardinal Health 200, LLC	The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is
2026-07-20	Medline Industries, LP	Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the ap
2026-07-14	Cardinal Health 200, LLC	Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability o
2026-07-14	AVID Medical, Inc.	Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach th
2026-07-10	Medline Industries, LP	Kits contain a potentially contaminated component which were recalled by the manufacturer
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

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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.