Santa Ana, CA, United States
Tenacore LLC recalls
1 recall recorded since 2018, most recently on 25 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 25 February 2021
- Terminated
- 5 August 2024
- Reason
- Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
- Distribution
- US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1332-2021, Z-1331-2021
- Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
- Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.