Food, drugs, devices › American Contract Systems, Inc.
Device recall: Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenienc
American Contract Systems, Inc. (Chandler, AZ) initiated this device recall on 31 Jan 2025; FDA lists 3 product records under event 96321, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. American Contract Systems, Inc. has 22 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
American Contract Systems, Inc., Chandler, AZ.
Reason for recall
"Sterility assurance with procedure trays"
Distribution
"US: AZ OUS: None"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1424-2025 | Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No | 800 | Class II | Ongoing | 2 Apr 2025 |
| Z-1425-2025 | Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No | 500 kits | Class II | Ongoing | 2 Apr 2025 |
| Z-1426-2025 | Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No | 460 kits. | Class II | Ongoing | 2 Apr 2025 |
Context
Other enforcement events for American Contract Systems, Inc.
All 22 events for American Contract Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Sterility assurance with procedure trays"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: AZ OUS: None"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.