CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
Banner Health Systems Cysto Pack recalled by American Contract Systems
American Contract Systems is recalling Banner Health Systems Cysto Pack, distributed in Arizona. The recall was initiated on 31 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1424-2025
- FDA event ID
- 96321
- Recalling firm
- American Contract Systems, Chandler, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jan 2025
- FDA classified
- 21 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 31 Jan 2025 | Recall initiated by company | |
| 21 Mar 2025 | Classified by FDA | +49 days |
| 2 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility assurance with procedure trays
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Where it was distributed
US: AZ OUS: None
Questions about this recall
Why was it recalled?
Sterility assurance with procedure trays
Which lots are affected?
Lot Code: UDI-DI: 00191072234261; Lot:9221789; Exp: 01/21/2026
Where was it sold?
US: AZ OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96321This product is part of a recall event; the main page for the event is Banner University Med Ctr Cardiac Cath Lab Pack recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Banner University Med Ctr Cardiac Cath Lab Pack recalled | American Contract Systems | Sterility | AZ | |
| CLASS II | Banner Health Systems Lap Pack recalled by American Contract Systems | American Contract Systems | Sterility | AZ |
More recalls from American Contract Systems
All 213| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
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