MalfunctionGDY
VISTEC
Received Jun 29, 2026 · Event occurred Jun 4, 2026
Report 1423537-2026-00210 · MDR key 25659983
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7318Catalog number
7318
Lot number
26B048162
Product problems
- Component Missing
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT ONLY 9 RAYTEC SPONGES FOUND IN 8 X 4 VISTEC SPONGE PACK (INSTEAD OF 10).
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.