Class 2 Device Recall Decomat

• Date Initiated by Firm: March 25, 2003
• Date Posted: June 05, 2003
• Recall Status: Terminated on January 14, 2004
• Recall Number: Z-0908-03
• Recall Event ID: 26011
• 510(K)Number: K920413
• Product Classification: Disinfector, Medical Devices - Product Code MEC
• Product: Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
• Code Information: Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.
• FEI Number: 1314329
• Recalling Firm/ Manufacturer: Getinge/Castle, Inc.; 1777 E Henrietta Road; Rochester NY 14623
• For Additional Information Contact: Mark N. Smith; 585-272-5274
• Manufacturer Reason for Recall: Hot water may splash from the washer chamber creating a burn hazard.
• FDA Determined 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.
• 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.

• 510(K) Database: 510(K)s with Product Code = MEC