VISTEC
Received Jan 9, 2026
Report 1423537-2026-00006 · MDR key 24019971
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7317Catalog number
7317--
Lot number
25K009162
Product problems
- Component Missing
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED ONLY 9 EA SPONGES INSIDE THE SEALED TRAY. THE KIT COULD NOT BE USED SINCE ALL 10 EACH WEREN'T ACCOUNTED FOR IN THE PACK.
Additional Manufacturer Narrative
A NON-CONFORMANCE (NC) REVIEW WAS CONDUCTED FOR LOT 25K009162 AND THERE WERE NO NCS RELATED TO THE REPORTED EVENT ISSUED DURING THE MANUFACTURING OF THIS LOT. A PHYSICAL SAMPLE WAS NOT RETURNED FOR INVESTIGATION. A PHOTO WAS PROVIDED BUT ONLY SHOWS THE LABEL OF THE PRODUCT WITH THE COUNT WRITTEN ON IT. BASED ON ALL AVAILABLE INFORMATION, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.