# FDA recall Z-1332-2021

> **Tenacore LLC** · Class I · device recall initiated 2021-02-25.

## Product

Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

## Reason for recall

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

## Key facts

- **Recall number:** Z-1332-2021
- **Recalling firm:** Tenacore LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-25
- **Report date:** 2021-04-14
- **Termination date:** 2024-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Ana, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1332-2021

## Citation

> AI Analytics. FDA recall Z-1332-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1332-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*