Recall Class: Class I
Date Recalled Initiated: June 3, 2015
Device: Alaris Medley Large Volume Pump (LVP) Frame Membrane
- Part and Lot numbers:
- Frame Membrane NOEM, Part # TC10006587 / 10013801 (Lot # 022015502 and 0421151000)
- Frame Membrane NOEM Shipped with LVP Bezel Assembly, Part # 49000204 (Lot # 031815100, 032415100 and 043015215)
- Manufactured from: February 20, 2015 to April 21, 2015
- Distributed from: February 25, 2015 to May 8, 2015
- Devices Recalled in the U.S.: 1,502
Use: The Alaris Medley Large Volume Pump (LVP) is an infusion pump used to deliver fluids such as nutrients and medications into a patient’s body in controlled amounts. The frame membranes are part of the pump that prevents fluids from leaking into internal components. Infusion pumps are widely used in clinical settings such as hospitals, nursing homes, and in the home.
Elite Biomedical Solutions LLC
756 Old States Route 74, Suite C
Cincinnati, OH 45245
Reason for Recall: Elite Biomedical Solutions discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or death.
Customers can contact Elite Biomedical Solutions, LLC at 1-855-291-6701, Monday through Friday between 8:00 a.m. and 5:00 p.m., Eastern Time.
FDA District: Cincinnati District Office
More information about this Recall:
On May 21, 2015, Elite Biomedical Solutions sent their customers a Product Advisory Notices. On June 3, 2015, the firm sent their customers an Urgent: Medical Device Part Recall letters. And on June 12, 2015, a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US.
In these communications, customers were instructed to take the following actions:
- Immediately examine your inventory and quarantine the affected product.
- If the affected product was further distributed, please identify your customers and notify them at once of this product recall.
- Regardless of whether you have the affected product, complete the Reply Form as soon as possible and return it to Elite Biomedical Solutions.
- Elite Biomedical Solutions will provide your facility with a replacement part for each affected frame membrane, along with a label for product return. Forward a copy of the letter to any facility to which you have further distributed affected product.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online, by regular mail or by FAX.