PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 14, 2019 Initiated: July 1, 2019 #Z-2161-2019

Product Description

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.

Reason for Recall

Potential for sterile packaging to be compromised

Details

Units Affected
From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each
Distribution
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.
Location
Williamston, MI

Frequently Asked Questions

What product was recalled?
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.. Recalled by Centurion Medical Products Corporation. Units affected: From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each.
Why was this product recalled?
Potential for sterile packaging to be compromised
Which agency issued this recall?
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2161-2019.