GETINGE 46-SERIES recallZ-1391-2020 · Maquet Cardiovascular Us Sales, Llc · initiated Jan 16, 2020

Why it was recalled

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.

FDA root cause category: Employee error

What the company is doing

Getinge issued an Urgent Medical Device Recall Correction letter to U.S. consignees via FedEx Priority Overnight delivery with signature proof of delivery on January 16, 2020. Letter provides identification of the issue, health risk and action to take. Customers were advised to examine your inventory immediately, complete and sign the MEDICAL DEVICE RECALL - RESPONSE FORM to acknowledge that you have received this notification, return the completed form to Getinge Disinfection AB by e-mailing a scanned copy to [email protected] or by faxing the form to 1-800-574-5051. Should you have one or more Getinge 46-Series Washer Disinfectors (models 46-4-502 and 46-4-503) you will be contacted by a Getinge Service Representative to schedule on-site service of your device, free of charge, by a Getinge Service Representative. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.

Recall details

Recall number

Z-1391-2020

Status

Terminated

Initiated by the company

Jan 16, 2020

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Quantity

7 units

Product code

MEC

Distribution

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

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• GETINGE 46-SERIES 46-4

  Getinge Disinfection AB · Disinfector, Medical Devices
  1 recall2 reports

Product lines

• GETINGE 46-SERIESGetinge Disinfection AB · 3 models · 4 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 84885).

• Z-1390-2020 · Terminated
  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…