Z-2372-2015 Class I Terminated
FDA device recall Z-2372-2015 was initiated by Elite Biomedical Solutions LLC on June 3, 2015 and is designated Class I. Reason for recall: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. The recall status is terminated (terminated March 7, 2017). Affected quantity: 346 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2015
- Initiation Date
- June 3, 2015
- Termination Date
- March 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 346 units
Product Description
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.
Reason for Recall
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Distribution Pattern
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.
Code Information
P/N 49000204 Lot #'s 031815100, 032415100, 04061545 and 043015215