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Medline Industries, Inc. ECVC6225ARecalls & reported problems

Centurion Medical Products Corporation · CVC BUNDLE KIT · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653160333418), received between Mar 8, 2021 and Jan 24, 2023 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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. Jan 7, 2026Open, Classified

    Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

    Z-2092-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Component Missing1
  • Crack1
  • Pressure Problem1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 24, 2023Component Missing

    NURSING WAS ASSISTING PHYSICIAN WITH LEFT IJ TRIPLE LUMEN CATHETER PLACEMENT. WHEN THE PHYSICIAN OPENED THE SUTURE PACKAGING TO SECURE THE NEWLY PLACED LINE, THE PACKET WAS EMPTY. THE SUTURE WAS UNABLE TO BE LOCATED IN THE REST OF THE KIT. NO KNOWN HARM TO PATIENT. EXTRA EQUIPMENT NEEDED TO BE OBTAINED TO COMPLETE THE PROCEDURE. MINOR DELAY. MANUFACTURER RESPONSE FOR CARDIAC CATHETERIZATION KIT, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16232732 ↗
  • MalfunctionMar 8, 2021Crack; Pressure Problem

    MIDDLE-AGED FEMALE WITH HISTORY OF DIABETES, HYPERTENSION, (B)(6), ESOPHAGEAL VARICES AND ASYSTOLE ARREST X 1. NEEDLE USED TO ACCESS VESSEL FOR TRIPLE LUMEN INSERTION HAD A CRACKED HEAD. THIS PREVENTED NEGATIVE PRESSURE FROM BEING APPLIED WHEN ATTEMPTING TO ACCESS VESSEL. PATIENT STUCK MULTIPLE TIMES BEFORE THE PROBLEM WAS IDENTIFIED. NO KNOWN HARM TO PATIENT AT THIS TIME.

    Patient problems: Insufficient Information

    MAUDE report 11434943 ↗

Other Cardiac catheterization kit devices

All Cardiac catheterization kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.