Class I — Elite Biomedical Solutions LLC
| Recalling firm | Elite Biomedical Solutions LLC |
|---|---|
| Registered facility | Elite Biomedical Solutions LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. |
| 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. |
| Quantity | 609 pieces |
| Distribution | Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI. |
| Initiated | 2015-06-03 |
| Classified | 2015-08-19 |
| Terminated | 2017-03-07 |
| Recall number | Z-2371-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Elite Biomedical Solutions LLC (Z-2371-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71543/
Alerts for Elite Biomedical Solutions LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.