Banner University Med Ctr Cardiac Cath Lab Pack: Sterility Risk in Procedure Trays
Banner University Med Ctr recalls Cardiac Cath Lab Pack-170278 (GSCC40G) due to potential sterility issues with procedure trays. Affected units may not meet sterility standards for medical procedures.
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Sterility assurance with procedure trays
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What happened, in plain English
American Contract Systems Inc. recalls Banner University Med Ctr's Cardiac Cath Lab Pack-170278 (model GSCC40G) because procedure trays may not maintain sterility. This could lead to infections during medical procedures if used improperly. Read more at govinfonow.com/recall/52985-banner-university-med-ctr-cardiac-cath-lab-pack-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/52985-banner-university-med-ctr-cardiac-cath-lab-pack-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1426-2025
Cite this page
“Banner University Med Ctr Cardiac Cath Lab Pack: Sterility Risk in Procedure Trays.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52985-banner-university-med-ctr-cardiac-cath-lab-pack-sterility-risk. Based on FDA recall #Z-1426-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2025%22&limit=1).
Why it’s dangerous
The procedure trays in this kit may not maintain sterility during medical procedures. If contaminated, they could lead to infections in patients during cardiac catheterization. This risk is specific to the trays' handling and storage.
Who’s affected
Healthcare professionals using this cardiac catheterization lab kit in medical facilities are most at risk. Patients undergoing procedures with this kit could be affected if sterility is compromised.
How to tell if you have this one
Check for the model number GSCC40G on the product label. The kit was sold with lot code 9219618 and expires January 21, 2026. This recall applies to medical facilities using the Banner University Med Ctr Cardiac Cath Lab Pack.
- Brand
Banner University Med Ctr- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US: AZ OUS: None
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1424-2025 | Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No; Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026 | 800 |
| 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; Lot Code: UDI-DI: 00191072233776; Lot: 9219420; Exp: 01/21/2026 | 500 kits |
| 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; Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026 | 460 kits. |
What to do — step by step
Check Product Label
Look for the model number GSCC40G on the product label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in Arizona.
FDA distribution: “US: AZ OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1426-2025 (January 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1426-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.