S40
Received May 7, 2026 · Event occurred Apr 6, 2026
Report 3003950207-2026-00013 · MDR key 25110549
Device
Generic name
Sterilant
Manufacturer
Steris CorporationModel number
S4000Catalog number
S4000
Lot number
(10)322AF07185
Product problems
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED PRIOR TO A PATIENT PROCEDURE THAT THE BAR CODES ON THEIR S40 STERILANT WERE "BLURRY" AND "SMEARED" AND WERE UNABLE TO BE READ BY THE BAR CODE SCANNER. REPORT OF PROCEDURE POSTPONEMENTS AS INSTRUMENTS WERE NOT ABLE TO BE PROCESSED FOR USE IN PROCEDURES. NO REPORT OF INJURY.
Additional Manufacturer Narrative
THE S40 STERILANT SUBJECT OF THE REPORTED EVENT IS BEING RETURNED TO STERIS FOR EVALUATION. INVESTIGATION IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.