Rika Plasma Bottle 21300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05020583213005), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 9, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED TO TERUMO BCT CUSTOMER SUPPORT THAT A LEAK WAS DISCOVERED AT THE DISCONNECT ON ARIKA DEVICE BECAUSE THE BLACK TOP WAS NOT PROPERLY SEALED ONTO THE BOTTLE. THE CUSTOMER STATED THAT THE BOTTLE WAS NOT PROPERLY SEALED TO THE LID, THEREFORE RESULTING IN A CONTAMINATED RETURN. THE PATIENT ID IS UNKNOWN AT THIS TIME. PER THE CUSTOMER THIS WAS LISTED AS AN UNCOMMON DONATION EVENT WAS OPENED AT CENTER LEVEL. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476338 ↗