Recall Z-2372-2015— Elite Biomedical Solutions LLC
Class I · Terminated
Class I FDA medical device recall by Elite Biomedical Solutions LLC, initiated 2015-06-03, terminated 2017-03-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death..
- Recalling firm
- Elite Biomedical Solutions LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-06-03
- Terminated
- 2017-03-07
- Firm location
- Cincinnati, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.