SECURE® 58719Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20812496011859), received between May 19, 2021 and May 28, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K843523); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 13, 2017Terminated

   The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

   Z-3240-2017 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 8 UNITS OF SECURE 100 ML 2 PORT PVC BAGS. THE PARTICULATE WAS NOTED BY THE PHARMACY UPON INSPECTION AFTER THE BAGS WERE FILLED WITH VASOPRESSIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901240 ↗
• MalfunctionMay 19, 2021Contamination; Contamination

  IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 13 UNITS OF THE SECURE 100 ML 2 PORT PVC BAGS, LOT 58719-31578. THE PARTICULATE WAS NOTED BY THE PHARMACY UPON INSPECTION AFTER THE BAGS WERE FILLED. THERE IS NO REPORT OF PATIENT INJURY OR DEATH. THE PARTICULATES ARE IN THE PROCESS OF BEING ANALYZED BY A THIRD PARTY LABORATORY. INITIAL VISUAL RESULTS INDICATE SCRAPE MARKS ON THE INTERIOR OF THE INJECTION SITE WHICH MAY BE CONSISTENT WITH NEEDLE CONTACT WITH THE INJECTION SITE WALL DURING THE FILLING OF THE BAG. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848208 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K843523. One submission often covers many models, so check the product and lot details in each record.

• Z-2261-2016 · Jun 23, 2016 · Terminated
  Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.