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Recall Observatory FDA recall evidence

Device 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.

Z-2161-2019

July 01, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 83329
Status
Terminated
Classification
Class II
Quantity
From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each
Official record key
device-enforcement:Z-2161-2019

Official wording

Reason: Potential for sterile packaging to be compromised

Code information: Lot # 2019041790 Exp 3/31/2024 Lot # 2019030490 Exp 2/29/2024

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging to be compromised