Recall Z-2161-2019— Centurion Medical Products Corporation

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-07-01, terminated 2020-06-26. FDA's recall record names no specific 510(k) clearance for this event. 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: Potential for sterile packaging to be compromised.

Recalling firm
Centurion Medical Products Corporation
Classification
Class II
Status
Terminated
Initiated
2019-07-01
Terminated
2020-06-26
Firm location
Williamston, MI, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.