MalfunctionGDY
VISTEC
Received May 8, 2026
Report 1423537-2026-00148 · MDR key 25125901
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7318Catalog number
7318
Lot number
25L018362
Product problems
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT RAY-TEC SPONGES WERE INSPECTED PRIOR TO USE AT THE OR GENERAL SURGERY. DURING INSPECTION, RAY-TEC SPONGE WERE FOUND TO HAVE FIBER SEPARATING AND SHEDDING. THE ISSUE WAS NOTICED DURING PREPARATION. THERE WAS NO HARM REPORTED.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.