Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Conveni
Summary
The FDA issued a Class II for Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Numbe by American Contract Systems, Inc.. Reason: Sterility assurance with procedure trays.
Details
Source
Device Recall
External ID
Z-1424-2025
Action Date
2025-04-02
Status
Ongoing
Category
device
Product Description
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Lot/Code Info: Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026
Quantity Affected: 800
Reason for Recall
Sterility assurance with procedure trays
Distribution
US: AZ OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-31
Company
Chandler, AZ
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 216 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-1424-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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