Low Pressure Connector Tubing LPDCT 160 (UDI 00616258021980)Recalls & reported problems

Bayer Medical Care Inc. · ASSY,TBG,LPDCT,60”,COILED,MC,WLD2 (86661004) · Class 2

Data updated Oct 18, 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 00616258021980), received between May 20, 2021 and May 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Manufacturing, Packaging or Shipping Problem1

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.

MalfunctionMay 20, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING A CT SYRINGE DISPOSABLE (LPDCT), A FOREIGN MATERIAL WAS VISUALIZED IN THE TUBING. THE CUSTOMER ELECTED NOT TO USE THE PRODUCT. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11855365 ↗

Device details

UDI-DI	`00616258021980`
Brand	Low Pressure Connector Tubing
Model	LPDCT 160
Company	Bayer Medical Care Inc.
Product code	DOY · Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 9, 2023

Device type (GMDN): Radiographic procedure tubing

A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Other Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. devices

Low Pressure Connector Tubing LPDCT 160
Bayer Medical Care Inc. · Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
1 report

All Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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