FDA Recall
Terminated
System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
Recall: Z-1182-2008
·
Initiated February 11, 2008
Recall
- Recall Number
- Z-1182-2008
- Event Number
- 46877
- Firm
- Custom Ultrasonics, Inc.
- FEI Number
- 2523209
- Product Code
- KOG
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- February 11, 2008
- Posted
- March 7, 2008
- Terminated
- September 3, 2009
- Address
- 144 Railroad Dr, Ivyland, PA, 18974-1449
Description
System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
Reason
Inadvertent selection of the "wash" cycle
Action
The recalling firm issued a Product Correction letter dated 2/11/08 to its customers informing them of the problem and the correction choices. The letter states that a key cover is available to reduce the error in the future and will be provided to each users upon return of the recall letter notification questionnaire.
Distribution
Worldwide; USA medical facilities and physicians and Canada
Quantity
3,190 units