# FDA recall Z-2444-2018

> **NewDeal SA** · Class II · device recall initiated 2018-05-22.

## Product

ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S,  181001S, 181002S, 181003S & 181004S

## Reason for recall

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

## Distribution

CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI

## Key facts

- **Recall number:** Z-2444-2018
- **Recalling firm:** NewDeal SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-22
- **Report date:** 2018-07-25
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** St Priest, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2444-2018

## Citation

> AI Analytics. FDA recall Z-2444-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2444-2018. Source: US FDA. Licensed CC0.

---

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