FDA-Device2015-06-24Class II
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
CooperSurgical, Inc.
Hazard
A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
Sold states
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
Affected count
200 units
Manufactured in
75 Corporate Dr, Trumbull, CT, United States
Products
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1814-2015Don't want to check this manually?
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