Summary
The FDA issued a Class II for CYSTO , Model No SACY80R by American Contract Systems Inc. Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged .
Details
Source
Device Recall
External ID
Z-1346-2025
Action Date
2025-03-26
Status
Ongoing
Category
device
Product Description
CYSTO , Model No SACY80R
Lot/Code Info: UDI-DI 00191072223425 Lots 70-51139 70-052248 70-052564 70-052954
Quantity Affected: 144 kits
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Distribution
US Nationwide distribution in the state of OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-06
Company
Tiffin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems Inc have FDA actions?
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1346-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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