STERILIZATION TEST STRIPS
Received Jul 8, 2026
Report MW5190397 · MDR key 25746891
Device
Generic name
Indicator, Physical/chemical Sterilization Process
Manufacturer
Solventum Us Llc.Model number
1243RE, 1243ALot number
SSO042029
Product problems
- Improper Chemical Reaction
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
STEAM INDICATOR DYE STRIPS ARE NOT INTACT AND REFLECT A REACTION PRIOR TO INTRODUCTION SURGICAL SETTING. PT: 4582. DEVICE: 2978, 2952. REFERENCE REPORT # MW5190392, MW5190393, MW5190394, MW5190395, MW5190396, MW5190398, MW5190399, MW5190400, MW5190401, MW5190402, MW5190403, MW5190404, MW5190405, MW5190406, MW5190407, MW5190408, MW5190409, MW5190410, MW5190411, MW5190412, MW5190413, MW5190414, MW5190415, MW5190416, MW5190417, MW5190418, MW5190419, MW5190420, MW5190421, MW5190422, MW5190423, MW5190424. THIS REPORT CAPTURES STERILIZATION TEST STRIPS #6.