CARDINAL HEALTH SAN5BCLSMKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439230321), received between Jul 23, 2019 and Dec 13, 2019 — classified as 2 malfunctions.

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-2327-2024 · Root cause: Device Design · Recall details · 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.

• MalfunctionDec 13, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING BLUE NON-XRAY COTTON TOWELS, 101625, FROM THE CATH LAB ACCESSORY TRAY/ SAN5BCLSMK. THE PROCEDURE PERFORMED WAS AN CORONARY ANGIOGRAM. THE COTTON TOWELS WERE USED OVER STERILE DRAPES TO HOLD DOWN EQUIPMENT ON THE STERILE FIELD. THE STAFF CHANGED OUT THE FLUSH BASIN CAUSING MINIMAL DELAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468192 ↗
• MalfunctionJul 23, 2019Material Fragmentation

  THE CUSTOMER REPORTED THREADS COMING OUT OF OR OFF OF THE BLUE NON-XRAY COTTON TOWELS 101625 FROM THE CATH LAB ACCESSORY TRAY/ (B)(4). THE PROCEDURE PERFORMED WAS AN ANGIOGRAM. THE COTTON TOWELS WERE USED AS A MAT TO LAY THE INSTRUMENTS ON WHERE THE INSTRUMENTS WOULD SLIP THROUGH THE WEAVE OF THE TOWEL CATCHING THREADS. THE STAFF WAS ABLE TO CATCH ANY LOOSE THREADS BEFORE USE ON THE PATIENT. THE INSTRUMENT WAS THEN WIPED OFF USING A WET 4X4 GAUZE SPONGE CAUSING MINIMAL DELAY. THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818042 ↗