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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Banner Health Systems Medical Procedure Trays Recalled for Sterility Issues

Agency Publication Date: March 21, 2025
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Summary

American Contract Systems, Inc. is recalling 1,760 medical procedure trays and packs sold under the Banner Health Systems and Banner University Medical Center brands. The recall includes Cysto Packs, Lap Packs, and Cardiac Cath Lab Packs used in medical facilities. These kits are being recalled due to sterility assurance issues with the procedure trays, which could potentially lead to infections if used during medical procedures. No incidents or injuries have been reported at this time.

Risk

The loss of sterility in these medical procedure trays could introduce bacteria or other contaminants during clinical procedures. This poses a risk of infection to patients who are treated using instruments from the affected kits.

What You Should Do

  1. This recall affects Banner Health Systems and Banner University Medical Center procedure kits, including Cysto Packs (model BHCY31E), Lap Packs (model BHLP62H), and Cardiac Cath Lab Packs (model GSCC40G).
  2. Check your inventory for lot numbers 9221789, 9219420, or 9219618. Affected kits have an expiration date of January 21, 2026.
  3. Stop using the recalled device. Contact American Contract Systems, Inc. or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Cysto Pack (Convenience Kit)by Banner Health Systems
Model / REF:
BHCY31E
Lot Numbers:
9221789 (Exp 01/21/2026)
UDI:
00191072234261
Product: Lap Pack - 170307 (Convenience Kit)by Banner Health Systems
Model / REF:
BHLP62H
Lot Numbers:
9219420 (Exp 01/21/2026)
UDI:
00191072233776
Product: Cardiac Cath Lab Pack-170278 (Convenience Kit)by Banner University Med Ctr.
Model / REF:
GSCC40G
Lot Numbers:
9219618 (Exp 01/21/2026)
UDI:
00191072182845

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96321
Status: Active
Manufacturer: American Contract Systems, Inc.
Sold By: Banner Health Systems; Banner University Medical Center
Manufactured In: United States
Units Affected: 3 products (800; 500 kits; 460 kits.)
Distributed To: Arizona

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.