Medical device kit recalled due to inability to confirm sterilization assurance
American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.
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: FDA Class II medical device recall involving inability to confirm sterilization of a medical device, which presents a theoretical risk of contamination and infection. No illnesses or injuries reported prevent a higher classification.
Plain-English summary
American Contract Systems, Inc. has recalled the Cysto medical convenience kit (Product UDI-DI: 00191072189295, Lot 2405033, expiration date 05/03/2025) in a quantity of 36 units.
The recall was initiated after the manufacturer identified that a humidity chart recorder in one of its controlled environment areas became inoperable. This malfunction resulted in humidity readings that fell outside acceptable specifications. Due to this monitoring failure, American Contract Systems is unable to confirm that the product met sterilization assurance requirements.
The affected product was distributed nationwide to Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
No illnesses or injuries have been reported to date. Facilities that received this product should contact the manufacturer for guidance on appropriate next steps.
The recalled product
- Product
- Cysto, FTCY03L; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 36
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)
- UDI-DI: 00191072189295
- Lot: 2405033
- Exp: 05/03/2025
Distribution
Part of a larger recall action
This product is one of 19 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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