Recall Z-0458-2021— Steris Corporation
Class III · Terminated
Class III FDA medical device recall by Steris Corporation, initiated 2020-10-07, terminated 2021-07-14. It names one FDA 510(k) clearance: K181865. Product: Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN. Reason: Potential for cleaning solution intrusion into endoscope.
- Recalling firm
- Steris Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-10-07
- Terminated
- 2021-07-14
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Reason for recall
Potential for cleaning solution intrusion into endoscope
Data sourced from openFDA. This site is unofficial and independent of the FDA.