Elite Biomedical Recalls Alaris Medley LVP Frame Membranes
Elite Biomedical Solutions LLC is recalling 609 Alaris Medley LVP Frame Membranes because the defect could allow fluid intrusion, potentially leading to injury or death.
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 source text explicitly states that the defect has the potential to cause injury or death, which aligns with the rubric criteria for a Severe (4) rating involving significant injury or death reports/potential.
Plain-English summary
Elite Biomedical Solutions LLC is recalling 609 pieces of the Alaris Medley LVP Frame Membrane. This component is used in the Alaris Medley LVP 8100 infusion pump to hold the platen assembly and protect the bezel assembly's internal components from fluid intrusion.
The recall was initiated because the defective membrane may fail to protect the pump's internal components from fluid. The source text states that the administration of inappropriate quantities of fluid can result from this failure, with the potential to cause injury or death.
The affected products were distributed nationwide in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA, and WI. The specific parts are identified by P/N TC10006587 and 10013801, with Lot Numbers 022015502 and 0421151000. Users of the Alaris Medley LVP 8100 infusion pump should check their equipment for these part and lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
- Manufacturer
- Elite Biomedical Solutions LLC
- Affected units
- 609
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)
- P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Elite Biomedical Solutions LLC 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 2 products in this recall →Related recalls
Same manufacturer · Elite Biomedical Solutions LLC
See all →- CriticalElite Biomedical Recalls Alaris Medley LVP Bezel Assemblies
FDA (Devices) · 2015-08-26
Same hazard · fluid intrusion
See all →- HighBerchtold TELETOM Equipment Management System Recall for Control Malfunction
FDA (Devices) · 2015-10-28
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