Z-2371-2015Class I

Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's...

Name: Z-2371-2015 Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's...
Creator: Elite Biomedical Solutions LLC
Published: 2015-06-03
License: https://open.fda.gov/license/

Elite Biomedical Solutions LLC / initiated 2015-06-03 / Terminated

FDA source

Elite Biomedical Solutions LLC began a recall of Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This... on 2015-06-03. FDA classified it as Class I and gives the reason as "Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2371-2015
Classification: Class I
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-08-20
Terminated: 2017-03-07
Recalling firm: Elite Biomedical Solutions LLC
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.
Product code: FRN Pump, Infusion
Reason for recall: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
FDA root cause: Other
Action: Elite Biomedical Solutions, sent a "Product Advisory Notices" letter dated May 21, 2015 to their customers. On June 3, 2015 the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the affected product , problem and actions to be taken. And on June 12, 2015 a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US. The notification letter requested customers to: 1) inspect and quarantine affected products, 2) identify your customers and notify them at once of this product recall, and 3) complete and return the enclosed response forms. For any questions, call Elite Biomedical Solutions, LLC, Quality Manager, at 1-855-291-6701.
Quantity in commerce: 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.
Product codes and lots: P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2371-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2371-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2372-2015	Class I	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)