Class I — Tenacore LLC
| Recalling firm | Tenacore LLC |
|---|---|
| Registered facility | TENACORE LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| Product | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 |
| Quantity | 1494 |
| Distribution | US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA |
| Initiated | 2021-02-25 |
| Classified | 2021-04-02 |
| Terminated | 2024-08-05 |
| Recall number | Z-1332-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Tenacore LLC (Z-1332-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87470/
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