AMSCO
Received Apr 8, 2026 · Event occurred Mar 9, 2026
Report 3005899764-2026-00027 · MDR key 24815799
Device
Generic name
Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201110311
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER WAS LEAKING WATER. NO REPORT OF INJURY.
Additional Manufacturer Narrative
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