ULTRACLAMP 5C4957 (UDI 07332414208233)Recalls & reported problems

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

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332414208233), received between Jun 9, 2025 and Jun 9, 2025 — classified as 1 malfunction.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ULTRA CLAMPS WERE NOT STOPPING THE FLOW. THIS WAS FURTHER DESCRIBED AS THE PATIENT ¿HAS TO USE UP TO THREE (3) CLAMPS AT A TIME SO THE THAT THE CLAMPS CAN PROPERLY STOP THE FLOW¿. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS 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 22169590 ↗

Device details

UDI-DI	`07332414208233`
Brand	ULTRACLAMP
Model	5C4957
Company	Baxter Healthcare Corporation
Product code	FKK · CLAMP, LINE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 18, 2025

Device type (GMDN): Medical tubing clip/clamp, temporary, non-calibrated, reusable

A non-sterile, manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a reusable device.

Other CLAMP, LINE devices

ULTRACLAMP 5C4957
Baxter Healthcare Corporation · CLAMP, LINE
2 reports

All CLAMP, LINE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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