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RenovaRP

GI Supply, Inc. · Model GIS-30 · UDI-DI 00893029002168

LRO Prescription
10
510(k) clearances
21,411
Adverse events (2 deaths)
1,064
Recalls
158
Facilities

Description

The RenovaRP® Tube Set is intended for use in conjunction with the RenovaRP Centesis Pump 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 Tube Set is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

Recalls

DateFirmReason
2026-08-11Medline Industries, LPThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu
2026-08-10AVID Medical, Inc.Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
2026-07-31Medline Industries, LPKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o
2026-07-29Cardinal Health 200, LLCThe 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
2026-07-23Medline Industries, LPThe kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a comprom
2026-07-20Medline Industries, LPDownstream 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
2026-07-14AVID Medical, Inc.Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
2026-07-14Cardinal Health 200, LLCCardinal 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
2026-07-14AVID 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
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer

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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.