FDA-Device2019-08-14Class II

STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.

Centurion Medical Products Corporation
Hazard

Potential for sterile packaging to be compromised

Sold states
US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
Affected count
From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each
Manufactured in
100 Centurion Way, N/A, Williamston, MI, United States
Products
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2161-2019

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