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U.S. Department of Health and Human Services

Class 3 Device Recall Getinge 46Series

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  Class 3 Device Recall Getinge 46Series see related information
Date Initiated by Firm January 16, 2020
Create Date February 27, 2020
Recall Status1 Terminated 3 on October 23, 2023
Recall Number Z-1390-2020
Recall Event ID 84885
Product Classification Disinfector, medical devices - Product Code MEC
Product 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.
Code Information Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. UDI Code 07340153700031
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Allison Jean Kaplan
973-709-7779
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Action 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 swic46-series.us@getinge.com 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.
Quantity in Commerce 4 units
Distribution U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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