The Recall Desk
HighFDA (Devices)·Z-1475-2020·Announced 2020-03-18

Getinge 88-Series Washer Disinfectors Recalled for Chamber Leakage Risk

Maquet Cardiovascular is recalling Getinge 88-Series washer disinfectors because ruptured spot welds may cause water leakage, posing slip and infection risks.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (slip and infection) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling Getinge 88-Series washer disinfectors, specifically Model 88-5 with Part Numbers 88-103 and 88-203. The recall involves 146 units distributed nationwide and in 34 foreign countries.

The recall is due to a potential defect where spot welds in the chamber may rupture, leading to water leakage. This leakage could create a hazardous situation for users, including the risk of slipping on wet surfaces or infection from contaminated water.

Users should identify their equipment by checking the serial numbers listed in the recall notice. If the equipment matches the affected serial numbers, users should contact Maquet Cardiovascular for instructions on how to proceed with the recall.

The recalled product

Product
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Affected units
146

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 88-203 07340153700116

Distribution

Distributed nationwide across the United States.