# FDA recall Z-2048-2021

> **RanD S.r.l.** · Class II · device recall initiated 2021-04-30.

## Product

Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120

## Reason for recall

The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products.  It was determined that some lots may not be sterile.

## Distribution

The products were distributed to the following US states:  FL, IL, TN, WI

## Key facts

- **Recall number:** Z-2048-2021
- **Recalling firm:** RanD S.r.l.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-30
- **Report date:** 2021-07-21
- **Termination date:** 2024-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Medolla, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2048-2021

## Citation

> AI Analytics. FDA recall Z-2048-2021. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-2048-2021. Source: US FDA. Licensed CC0.

---

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