The Recall Desk
ModerateFDA (Devices)·Z-0542-2016·Announced 2015-12-30

Ameditech Recalls Thermo Fisher 8 Drug Cassettes Due to Reduced Reactivity

Ameditech is recalling 100 Thermo Fisher 8 Drug Cassettes because they may show reduced reactivity for two specific benzodiazepine compounds.

What this means for you

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. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard like injury or death.

Plain-English summary

Ameditech Inc is recalling 100 units of the THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU. The recall is due to reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert.

The specific benzodiazepine compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. The affected products were distributed nationwide.

The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these products.

The recalled product

Product
THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
Manufacturer
Ameditech Inc
Affected units
100

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)

  • G150328

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.

See all 59 products in this recall →