Z-0908-03

Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB...

Name: Z-0908-03 Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB...
Creator: Getinge/Castle, Inc.
Published: 2003-03-25
License: https://open.fda.gov/license/

Getinge/Castle, Inc. / initiated 2003-03-25 / Terminated / root cause: design

FDA source

Getinge/Castle, Inc. began a recall of Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden on 2003-03-25. The reason FDA records is "Hot water may splash from the washer chamber creating a burn hazard". 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-0908-03
Status: Terminated
Initiated: 2003-03-25
Posted: 2003-06-05
Terminated: 2004-01-14
Recalling firm: Getinge/Castle, Inc.
Product: Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
Product code: MEC Disinfector, Medical Devices
Reason for recall: Hot water may splash from the washer chamber creating a burn hazard.
Root cause tag: design
FDA root cause: Device Design
Action: Letter dated 3/25/03 flagged: ''Important Safety Alert/Product Upgrade''. Customers advised to discontinue use until the field correction is performed.
Quantity in commerce: 75 units
Distribution: Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.
Product codes and lots: Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.

Product code MEC

K920413Class IIDecomat a 8666Getinge International, Inc. / cleared 1994-04-05

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)