Clean Catch Urine Kit Recalled Due to Improper Assembly
American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, indicating serious potential for harm. Although no illnesses or injuries are reported in the source material, the agency's classification mandates a minimum severity of 4 (Severe).
Plain-English summary
American Contract Systems, Inc. is recalling 274,400 Clean Catch Urine Kits (NS 178489, AHMU58A) distributed in Minnesota. The affected kits are from lots 891211, 737211, 699211, and 986221, with UDI-DI 00191072120557.
The recalled products were assembled off-site by individuals who may not have been properly trained. The FDA classified this as a Class I recall.
Consumers who have received or are using one of these kits should stop use of the affected lots and contact American Contract Systems, Inc. for information on replacement or return of the products.
The recalled product
- Product
- Clean Catch Urine Kit NS 178489, AHMU58A
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- Affected units
- 274,400
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 (4)
- UDI-DI: 00191072120557 Lots 891211
- 737211
- 699211
- 986221
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 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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