Recall Z-2372-2015 ยท FRN Pump, Infusion
Elite Biomedical Solutions LLC
Alaris Medley LVP Bezel Assembly. 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.
| Date | Aug 20, 2015 (initiated Jun 3, 2015) |
| Status | Terminated |
| Reason | Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. |
| 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 en |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.