Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal co

FDA device recall Z-2372-2015 · posted 2015-08-20 · Terminated

Recall details

Recalling firm

Elite Biomedical Solutions LLC

Reason for recall

Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FRN

Quantity affected

346 units

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.

Date initiated

2015-06-03

Date posted

2015-08-20

Date terminated

2017-03-07

Location

Cincinnati, OH