Z-1124-2021Class II

Getinge CM320 Series Washer Disinfector -

Name: Z-1124-2021 Getinge CM320 Series Washer Disinfector -
Creator: Getinge Group Logistics America, LLC
Published: 2020-12-21
License: https://open.fda.gov/license/

Getinge Group Logistics America, LLC / initiated 2020-12-21 / Terminated / root cause: design

FDA source

Getinge Group Logistics America, LLC began a recall of Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical... on 2020-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1124-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Posted: 2021-02-16
Terminated: 2022-07-20
Recalling firm: Getinge Group Logistics America, LLC
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.
Product code: MEC Disinfector, Medical Devices
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1124-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1124-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-16

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)