Device product
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Z-1814-2015
Product summary
- Event
- Event 71329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 units
- Official record key
device-enforcement:Z-1814-2015
Official wording
Reason: A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
Code information: Lot 153309
Distribution pattern: AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
Derived failure modes
-
Unknown
A diaphragm size 80 labeled box was incorrectly packaged with a size 85.