Arthromatic/Uromatic 2C4005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412000978), received between Feb 20, 2018 and May 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Packaging Compromised” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K960787); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGE OF A Y-TYPE TUR IRRIGATION SET WAS NOT SEALED PROPERLY. THE ISSUE WAS FURTHER DESCRIBED AS, "THE RED CAP OF THE SPIKE WAS PINCHED BY SEALING". THE RED CAP WAS STICKING OUT OF THE PACKAGING. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055350 ↗
• MalfunctionJan 14, 2021Filling Problem; No Flow; Filling Problem; No Flow

  IT WAS REPORTED A Y-TYPE TUR IRRIGATION SET WOULD NOT FLOW. .DURING PATIENT INFUSION, THE "FLOW WAS RESTRICTED". THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11172685 ↗
• MalfunctionOct 5, 2020Improper Flow or Infusion; Protective Measures Problem; Improper Flow or Infusion; Protective Measures Problem

  IT WAS REPORTED ¿FOAM AND SMALL AIR BUBBLES¿ WERE OBSERVED IN A Y-TYPE TUR IRRIGATION SET DURING A RAMUCIRUMAB INFUSION THIS WOULD RESULT IN AIR IN PUMP ALARMS VIA A SPECTRUM PUMP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10631366 ↗
• MalfunctionFeb 20, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED THAT THE STERILE PACKAGING OF THREE (3) Y-TYPE TUR IRRIGATION SETS WAS OPEN. THIS EVENT WAS DISCOVERED BEFORE PATIENT USE DURING THE KITTING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7284494 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960787. One submission often covers many models, so check the product and lot details in each record.

• Z-1010-2015 · Jan 14, 2015 · Terminated
  Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
• Z-1684-2013 · May 15, 2013 · Terminated
  Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended
• Z-1682-2013 · May 15, 2013 · Terminated
  Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the d
• Z-1683-2013 · May 15, 2013 · Terminated
  Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended