CT TRI-PAK Sterile Disposable Syringe CTP-200-FLS (UDI 00616258005430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00616258005430), received between Jan 30, 2017 and Mar 23, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (3 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED A FOREIGN PARTICULATE WITHIN THE LOW PRESSURE CONNECTOR TUBING (LPCT). NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9869155 ↗
• MalfunctionMar 19, 2019Particulates; Particulates

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE LOW PRESSURE CONNECTOR TUBING (LPCT). THE CUSTOMER ELECTED NOT TO USE THE TUBING. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8433963 ↗
• MalfunctionNov 12, 2018Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem

  THE SITE REPORTED THE FOLLOWING: A RADIOLOGY TECHNOLOGIST REPORTED THAT HE OPENED 3 CTP-200-FLS SYRINGE KITS FROM THE SAME BOX THAT HAVE A WHITE DUST ON THE SYRINGES. THE KITS WERE NOT USED FOR A PATIENT AND WERE REMOVED FROM THE AREA TO BE RETURNED FOR INVESTIGATION.

  Patient problems: Not Applicable

  MAUDE report 8059909 ↗
• MalfunctionNov 5, 2018Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem

  THE SITE REPORTED THE FOLLOWING: A RADIOLOGY TECHNOLOGIST REPORTED THAT HE OPENED A CASE OF CTP-200-FLS SYRINGE KITS FROM THE SAME BOX THAT HAVE A WHITE DUST ON THE SYRINGES. THE KITS WERE NOT USED FOR A PATIENT AND WERE REMOVED FROM THE AREA TO BE RETURNED FOR INVESTIGATION.

  Patient problems: Not Applicable

  MAUDE report 8037372 ↗
• MalfunctionSep 11, 2018Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem

  THE SITE REPORTED THE FOLLOWING: A RADIOLOGY TECHNOLOGIST REPORTED THAT HE OPENED 3 CTP-200-FLS SYRINGE KITS THAT HAVE A WHITE DUST ON THE SYRINGES. THE KITS WERE NOT USED FOR A PATIENT AND WERE REMOVED FROM THE AREA TO BE RETURNED FOR INVESTIGATION.

  Patient problems: Not Applicable

  MAUDE report 7863978 ↗
• MalfunctionJan 30, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE ENVISION CT DISPOSABLE KIT AND UPON INSPECTION, THEY NOTICED THE PRESENCE OF FINE WHITE PARTICLES AROUND THE SYRINGE AS WELL AS THE QUICK FILL TUBE (QFT). THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6285956 ↗