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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more…"
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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