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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge CM320 Series

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  Class 2 Device Recall Getinge CM320 Series see related information
Date Initiated by Firm December 21, 2020
Create Date February 16, 2021
Recall Status1 Terminated 3 on July 20, 2022
Recall Number Z-1124-2021
Recall Event ID 87155
Product Classification Disinfector, medical devices - Product Code MEC
Product Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items must be further processed through terminal sterilization before use in any surgical procedure.
Code Information Product Code/Part Number: CM320 4 WUWD, CM320 3 WWD, CM320K661, CM320K671, CM320K689, CM320K706, CM320K730, CM320WU, CM320WU K981, CM320WUWD.   Serial Number: 31253, 31260, 31299, 31286, W50026718, W50027250, W50029991, W50034570, W50039234, WAA070170, WAA081312, WAA062340, WAA062341, WAA070619, WAA085063, WAA089556, WAA093936, WAA094247, WAA070618.  UDI Code: 07340153700178 GETINGE CM320WO CM320 2 CHAMBER WO 07340153700185 GETINGE CM320WU CM320 2 CHAMBER WU 07340153700192 GET/NGE CM320WUWO CM320 4 CHAMBER WUWO 07340153700208 GETINGE CM320WWO CM320 3 CHAMBER WWO 07340153700215 GETINGE CM320WWWO CM320 4 CHAMBER WWWO 07340153710153 GETINGE CM320WOK966 CM320 2 CHAMBER WO
Recalling Firm/
Manufacturer		 Getinge Group Logistics America, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Rachana Patel
973-709-7412
Manufacturer Reason
for Recall		 The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.
FDA Determined
Cause 2		 Device Design
Action On 01/12/2021 Getinge initiated a voluntary Medical Device in the U.S for the CM320 Series Washer Disinfector instructing consignees to inspect their device and that a correction kit is currently available and the correction will be completed at no cost to affected customers.
Quantity in Commerce 189 units total (Domestic 19 units, Foreign 170 units)
Distribution Worldwide distribution - US Nationwide distribution including in the states of ND, PA, NC, VA, NE, MD, NY, MN and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Norway, Slovakia, Slovenia, South Korea, Sweden, Japan, China, Netherland, Italy, Kuwait and Czech Republic.
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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