Z-2161-2019Class II

STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST -

Name: Z-2161-2019 STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST -
Creator: Centurion Medical Products Corporation
Published: 2019-07-01
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-07-01 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of 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... on 2019-07-01. FDA classified it as Class II and gives the reason as "Potential for sterile packaging to be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2161-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-01
Posted: 2019-08-06
Terminated: 2020-06-26
Recalling firm: Centurion Medical Products, LP
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.
Product code: HDF Speculum, Vaginal, Metal
Reason for recall: Potential for sterile packaging to be compromised
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 1) Please identify all inventory that you have within your possession and segregate the recalled product. 2) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed. Please contact the number for any question (517) 546-5400 Ext.1122.
Quantity in commerce: 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.
Product codes and lots: Lot # 2019041790 Exp 3/31/2024 Lot # 2019030490 Exp 2/29/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2161-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2161-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2162-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2163-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2164-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2165-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2166-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2167-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2168-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2169-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2170-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2171-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2172-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2173-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code HDF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)