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ULTRACLAMP 5C4957 (UDI 00085412070643)Recalls & reported problems

Baxter Healthcare Corporation · UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container or any Baxter Y-Set. The clamp is specifically designed to assist individuals who experience difficulty in operating other ancillary clamps or pre-attached clamps. · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412070643), received between Jun 29, 2018 and Aug 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Hole In Material1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED AN UNSPECIFIED QUANTITY OF ULTRA CLAMPS CUT THE TUBING OF THE SOLUTION BAGS WHICH RESULTED IN LEAK. THIS OCCURRED DURING USE OF THE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15186966 ↗
  • MalfunctionJun 29, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

    IT WAS REPORTED THAT AN ULTRACLAMP TUBING CLAMP CAUSED A HOLE ON THE DRAIN TUBING DURING USE. THE HOME PATIENT STATED THAT WHILE CLAMPING THE DRAIN LINE TO WEIGH THE DRAIN BAG, THE FLUIDS WERE LEAKING OUT WHERE THE RED CLAMP WAS. 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 7652779 ↗

Other CLAMP, LINE devices

All CLAMP, LINE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.