Infusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.
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: This is an FDA Class I medical device recall. While the source does not report any deaths or injuries, FDA Class I recalls are classified as Severe per the rubric, which requires a minimum score of 4 for Class I recalls.
Plain-English summary
BioMedical Equipment Service Co (BMES) is recalling Alaris Infusion Pump Module Model 8100 units that were serviced or repaired using a non-original bezel repair part (TIPA-8100-4410). The third-party bezel replacement part may experience cracking or separation of the posts over time.
If the bezel posts separate from the bezel, the pump may experience free flow, over-infusion, under-infusion, or interruption of infusion. These conditions could result in serious patient harm.
Approximately 718 pump modules are potentially affected. The affected units were distributed to healthcare facilities in California, Illinois, Indiana, Kentucky, Louisiana, New Jersey, Nevada, Ohio, and Pennsylvania.
Healthcare facilities that have Alaris Infusion Pump Module Model 8100 units serviced by BMES should contact the company or the FDA for guidance on identifying affected units and determining appropriate next steps.
The recalled product
- Product
- Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
- Manufacturer
- BioMedical Equipment Service Co (BMES)
- Affected units
- 718
Distribution
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