Cysto Pack Procedure Trays Recalled Due to Sterility Assurance Issues
American Contract Systems, Inc. is recalling 800 units of Cysto Pack procedure trays (Model BHCY31E) distributed in Arizona due to sterility assurance concerns.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device (procedure tray) with sterility assurance issues. Although no illnesses or injuries have been reported, sterility failure in invasive medical device procedure kits creates a significant infection risk. FDA Class II classification supports this severity level.
Plain-English summary
American Contract Systems, Inc. is recalling the Cysto Pack (Model BHCY31E), a medical device convenience kit used as a procedure tray in healthcare settings.
The recall involves sterility assurance issues with the affected devices. Approximately 800 units bearing lot number 9221789 with an expiration date of January 21, 2026 were distributed in Arizona.
Affected healthcare facilities and users who have received these units should review the recall notice for instructions on next steps.
The recalled product
- Product
- Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Procedure Kit
- Hazard
- Affected units
- 800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: UDI-DI: 00191072234261
- Lot:9221789
- Exp: 01/21/2026
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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