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Terminated

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

FDA Recall Z-0908-03 · Posted 2003-06-05

Recalling FirmGetinge/Castle, Inc.
Recall StatusTerminated
Product CodeMEC
Date Initiated2003-03-25
Date Terminated2004-01-14
Product Quantity75 units

Reason for Recall

Hot water may splash from the washer chamber creating a burn hazard.

Firm Action

Letter dated 3/25/03 flagged: ''Important Safety Alert/Product Upgrade''. Customers advised to discontinue use until the field correction is performed.

Root Cause

Device Design

Distribution Pattern

Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920413DECOMAT A 8666Getinge International, Inc. · 1994-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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