Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
FDA device recall Z-0908-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Getinge/Castle, Inc.
- Reason for recall
- Hot water may splash from the washer chamber creating a burn hazard.
- Action taken
- 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
- Status
- Terminated
- Product code
- MEC
- Quantity affected
- 75 units
- Distribution
- Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.
- Date initiated
- 2003-03-25
- Date posted
- 2003-06-05
- Date terminated
- 2004-01-14
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DECOMAT A 8666 (K920413) | Getinge International, Inc. | 1994-04-05 |