FDAClass IIApril 2, 2025

Brand Name: Banner University Med Ctr. Product Name recall: Sterility Concern

Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product…

Why was Brand Name: Banner University Med Ctr. Product Name recalled?

Sterility assurance with procedure trays

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026

Product
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product…
Recalling firm
American Contract Systems, Inc.
Quantity
460 kits.
Distribution
US: AZ OUS: None
Recall date
April 2, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls