PowerPICC SOLO CK000458Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741104251), received between Feb 8, 2019 and Feb 12, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2019Expiration Date Error

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE NINTH KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331422 ↗
• MalfunctionFeb 11, 2019Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE EIGHTH KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329870 ↗
• MalfunctionFeb 11, 2019Expiration Date Error

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE TENTH KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329868 ↗
• MalfunctionFeb 11, 2019Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE SEVENTH KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329843 ↗
• MalfunctionFeb 11, 2019Expiration Date Error

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE SIXTH KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329841 ↗
• MalfunctionFeb 8, 2019Expiration Date Error

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE FOURTH KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324287 ↗
• MalfunctionFeb 8, 2019Expiration Date Error

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE FIFTH KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324284 ↗
• MalfunctionFeb 8, 2019Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE THIRD KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324283 ↗
• MalfunctionFeb 8, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE SECOND KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324282 ↗
• MalfunctionFeb 8, 2019Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE FIRST KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323985 ↗