The Recall Desk
HighFDA (Devices)·Z-1124-2021·Announced 2021-02-24

Getinge CM320 Washer Disinfector Recalled for Hose Deformation Risk

Getinge is recalling CM320 Series Washer Disinfectors because plastic inlet hose connections may deform or break, potentially causing water leaks and burns.

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 (burns) from a medical device defect, but no injuries or illnesses have been reported, fitting the criteria for a High severity score.

Plain-English summary

Getinge Group Logistics America, LLC is recalling 189 units of the Getinge CM320 Series Washer Disinfector. These devices are used in hospitals and central disinfection facilities to wash, disinfect, and dry surgical instruments, containers, and operating theatre accessories. The recall covers units distributed in the United States and internationally.

The recall is due to a potential defect where plastic inlet hose connections may deform or break as a result of material fatigue or over-tightening of the clamps. A broken hose connection could lead to water leakage or water spray, which may result in a burn to the user or procedural delays if the device is taken out of service.

Affected units are identified by specific product codes and serial numbers listed in the recall documentation. Users should contact Getinge for further instructions on how to address the issue.

The recalled product

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 disinfec

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 (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Same manufacturer · Getinge Group Logistics America, LLC

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