Device product

CYSTO , Model No SACY80R

Z-1346-2025

February 06, 2025

Class II

Product summary

Firm: American Contract Systems Inc
Event: Event 96343
Status: Ongoing
Classification: Class II
Quantity: 144 kits
Official record key: device-enforcement:Z-1346-2025

Official wording

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

Code information: UDI-DI 00191072223425 Lots 70-51139 70-052248 70-052564 70-052954

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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