Reported Nov 25, 2020 · Terminated
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible…
Steris Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual
- flexible endoscope cleaning Part number0600818OKN
- Lot codes and dates
Distributed from May 232017 to June 302020
- Amount recalled
- 293 units:248 units (USA); 45 units OUS
Where it was sold
- Nationwide
Why it was recalled
Potential for cleaning solution intrusion into endoscope
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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