# FDA recall Z-1391-2020

> **Maquet Cardiovascular Us Sales, Llc** · Class III · device recall initiated 2020-01-16.

## Product

Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.

## Reason for recall

Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.

## Distribution

U.S. Distribution: CA, CO, IA, MN, NY, SC, VA

## Key facts

- **Recall number:** Z-1391-2020
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-16
- **Report date:** 2020-03-04
- **Termination date:** 2023-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2020

## Citation

> AI Analytics. FDA recall Z-1391-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-1391-2020. Source: US FDA. Licensed CC0.

---

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