CARDINAL HEALTH SNE29NRCCCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488772707), received between Oct 17, 2019 and Oct 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 29, 2024Class IIOpen, Classified

   Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

   Z-2330-2024 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionOct 17, 2019Contamination /Decontamination Problem

  THE CUSTOMER HAD REPORTED THAT THE BLUE COTTON X-RAY OR TOWELS, OR-1727BXG, FROM THE NEURO INTERVENTIONAL PACK SNE29NRCCC WERE LINTING ONTO THE TOWELS, GUIDEWIRE, AND LIKELY A GLOVE DURING AN INTERVENTIONAL NEURO PROCEDURE. THE TOWELS WERE USED TO SQUARE OFF THE OPERATIVE SITE DURING PREP. THERE WAS MINIMAL DELAY AND NO INJURY OR HARM TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED BY THE CUSTOMER. AN MDR IS BEING FILED FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205306 ↗