Aftermarket Alaris Infusion Pump Front Bezel Recall for Potential Infusion Errors
Pacific Medical Group is recalling 2,452 aftermarket Alaris infusion pump front bezels installed between July 2020 and February 2021. The bezel posts may crack or separate, potentially causing infusion errors.
What this means for you
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: The recall involves a medical device defect that could lead to infusion errors (over-infusion, under-infusion, or interruption), which poses a risk of harm to patients. However, the source text does not report any specific illnesses or injuries, and the agency classification is Class I, which typically indicates a lower risk of adverse health consequences compared to Class II or III recalls in this context, but the potential for infusion errors in a medical device warrants a High severity rating under the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Pacific Medical Group Inc. is recalling 2,452 units of the Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel. These components were installed by Pacific Medical Group (doing business as Avante Health Solutions) during service or repair of infusion pump modules, rather than by the original manufacturer. The affected devices were serviced or purchased between July 10, 2020, and February 18, 2021, and were distributed nationwide in the United States.
The recall is due to a defect where the posts on the front bezel component may crack or separate over time. If one or more bezel posts separate, it could lead to free flow, over-infusion, under-infusion, or interruption of the infusion. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare facilities and consumers who have these specific aftermarket bezels installed should contact Pacific Medical Group for further instructions on how to address the issue. The recall number is Z-1375-2021.
The recalled product
- Product
- Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 2,452
Distribution
Distributed nationwide across the United States.
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