Ameditech DrugSmart Cup 10 Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling DrugSmart Cup 10 units because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, aligning with a Moderate severity score for a performance defect without reported injuries.
Plain-English summary
Ameditech Inc is recalling 272 units of DrugSmart Cup 10, Item No. 61093D-3C, 61085D, and 61015D. The recall is due to reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert.
The specific compounds affected by the reduced reactivity are Clonazepam and Chlordiazepoxide. The affected units were distributed nationwide.
The source text does not provide specific instructions for consumers or healthcare providers regarding the disposal or replacement of these units.
The recalled product
- Product
- DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 272
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)
- 143516 143977 150397 152070 152751
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by Ameditech 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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