—#212723

Product

CYSTO , Model No SACY80R

FDA product code: NWU — Endoscope Introducer Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UDI-DI 00191072223425 Lots 70-51139 70-052248 70-052564 70-052954

Why it was recalled

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Root cause (FDA determination)

Process control

Action the firm took

The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.

Recalling firm

Firm: American Contract Systems Inc
Address: 85 Shaffer Park Dr, Tiffin, Ohio 44883-9290

Distribution

Distribution pattern: US Nationwide distribution in the state of OH.

Timeline

Recall initiated: 2025-02-06
Posted by FDA: 2025-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212723. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.