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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Getinge Group Logistics America, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1124-2021
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