Device recall: STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of…

Class II FDA enforcement event 83329. Recall start date: 1 Jul 2019. Status in the FDA record: Terminated. Termination date: 26 Jun 2020.

Reason for recall, in the words of FDA

Potential for sterile packaging to be compromised

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Centurion Medical Products Corporation started this device recall on 1 Jul 2019. The firm address in the FDA record is in Williamston, MI. FDA put the recall in Class II. FDA event 83329 has 13 product records. The first FDA enforcement report date is 14 Aug 2019. The record gives the status Terminated, with the termination date 26 Jun 2020.

FDA enforcement report The 13 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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.

Recalling firm

Centurion Medical Products Corporation, Williamston, MI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

13 product records in the event.

FDA event 83329: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2161-2019	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.	From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each	Class II	Terminated	14 Aug 2019
Z-2162-2019	STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.	400 each	Class II	Terminated	14 Aug 2019
Z-2163-2019	CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.	220 each	Class II	Terminated	14 Aug 2019
Z-2164-2019	CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.	168 each	Class II	Terminated	14 Aug 2019
Z-2165-2019	NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.	120 each	Class II	Terminated	14 Aug 2019
Z-2166-2019	LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.	1224 each	Class II	Terminated	14 Aug 2019
Z-2167-2019	DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.	3250 each	Class II	Terminated	14 Aug 2019
Z-2168-2019	HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.	192 each	Class II	Terminated	14 Aug 2019
Z-2169-2019	DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.	1900 each	Class II	Terminated	14 Aug 2019
Z-2170-2019	DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.	6180 each	Class II	Terminated	14 Aug 2019
Z-2171-2019	UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.	4560 each	Class II	Terminated	14 Aug 2019
Z-2172-2019	LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.	3804 each	Class II	Terminated	14 Aug 2019
Z-2173-2019	SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.	48 each	Class II	Terminated	14 Aug 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 13Median of the firm: 2
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of Centurion Medical Products Corporation
Initiated	Product (first record)	Type	Class	Records
11 Dec 2019	Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRC	Device	Class II	54
24 Oct 2019	Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955	Device	Class II	1
28 Aug 2019	Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during ci	Device	Class II	2
15 Jul 2019	Port full Access Tray Product Code: DT19330	Device	Class II	4
24 Jun 2019	EPISTAXIS TRAY Kit Code: MNS10165	Device	Class II	3
7 Jun 2019	Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.	Device	Class I	1
1 Jun 2019	Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367	Device	Class II	1
24 Apr 2019	PICC Line Accessory Kit CVI4285	Device	Class II	33
29 Mar 2019	Sterile Nail Clipper Concave Edge (67710)	Device	Class II	2
23 Oct 2017	SKIN STAPLE REMOVER	Device	Class II	21

Centurion Medical Products Corporation: all 19 events

Official channels

FDA enforcement report Z-2161-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 83329. https://recallregister.com/fda/ii/83329/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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.
What quantity of product is in FDA event 83329?: The event has 13 product records. The first record gives this quantity: From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.