Z-2161-2019 Class II Terminated
FDA device recall Z-2161-2019 was initiated by Centurion Medical Products Corporation on July 1, 2019 and is designated Class II. Reason for recall: Potential for sterile packaging to be compromised The recall status is terminated (terminated June 26, 2020). Affected quantity: From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- July 1, 2019
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each
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
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.
Code Information
Lot # 2019041790 Exp 3/31/2024 Lot # 2019030490 Exp 2/29/2024