# FDA recall Z-2049-2021

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

## Product

Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099.  Thoracic/abdominal cavity drain catheter.

## 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-2049-2021
- **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-2049-2021

## Citation

> AI Analytics. FDA recall Z-2049-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2049-2021. Source: US FDA. Licensed CC0.

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