FDA recall Z-2161-2019

Product

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

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.

Key facts

Status

Terminated

Initiation date

2019-07-01

Report date

2019-08-14

Termination date

2020-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Williamston, MI, United States

Primary source

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