Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1390-2020 — Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 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.

U.S. FDA — Device Enforcement · United States · 2020-01-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1390-2020
Date of alert
2020-01-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Maquet Cardiovascular Us Sales, Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07340153700031
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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