CYSTO Model SACY80R Recall for Sterilization Assurance Failure
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
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 an FDA Class II medical device recall involving unconfirmed sterilization assurance. No hospitalizations, injuries, or illnesses have been reported. Per the rubric, Class II recalls without reported hospitalizations or injuries default to High (Score 3) when the hazard is theoretical rather than an actual reported harm.
Plain-English summary
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits distributed nationwide in Ohio. The affected devices are identified by UDI-DI 00191072223425 and lot numbers 70-51139, 70-052248, 70-052564, and 70-052954.
The manufacturer is unable to confirm that product sterilization assurance requirements were met. This creates uncertainty about whether the devices have been properly sterilized before distribution.
A lack of confirmed sterilization assurance could result in loss or lack of device functionality, potentially delaying or prolonging patient treatment. No illnesses or injuries have been reported to date.
Healthcare facilities and providers who have received these devices should cease use immediately and contact American Contract Systems Inc for instructions on return or replacement.
The recalled product
- Product
- CYSTO , Model No SACY80R
- Manufacturer
- American Contract Systems Inc
- Affected units
- 144
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 (1)
- UDI-DI 00191072223425 Lots 70-51139 70-052248 70-052564 70-052954
Distribution
Part of a larger recall action
This product is one of 32 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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