Low Pressure Connector Tubing LPDCT 160 (UDI 00616258005638)Recalls & reported problems
Bayer Medical Care Inc. · Envision, Vistron, MCT - Coiled 60" Low Pressure Connector Tube (SET, PKG, LPDCT 160, RAD, MC) (60728885) · 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 00616258005638), received between Mar 25, 2021 and Mar 25, 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.
MalfunctionMar 25, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING A CT SYRINGE KIT, A FOREIGN MATERIAL WAS VISUALIZED IN THE TUBING. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11569728 ↗
Other Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. devices
- Low Pressure Connector Tubing LPDCT 160Bayer Medical Care Inc. · Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.1 report
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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