Exact FDA event identifier

Event 83329

13 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 01, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Centurion Medical Products Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 13

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

Recall number: Z-2161-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 2 of 13

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.

Z-2162-2019

Recall number: Z-2162-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 400 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019020590 Exp : 8/31/2020

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.

device · product 3 of 13

CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.

Z-2163-2019

Recall number: Z-2163-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 220 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019052190 Exp : 9/30/2021

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.

device · product 4 of 13

CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.

Z-2164-2019

Recall number: Z-2164-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 168 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019051390 Exp: 8/31/2021

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.

device · product 5 of 13

NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.

Z-2165-2019

Recall number: Z-2165-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 120 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019043090 Exp: 8/31/2020

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.

device · product 6 of 13

LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.

Z-2166-2019

Recall number: Z-2166-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 1224 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019031190 Exp: 06/30/2020

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.

device · product 7 of 13

DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Z-2167-2019

Recall number: Z-2167-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 3250 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019052190 Exp: 4/30/2021

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.

device · product 8 of 13

HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Z-2168-2019

Recall number: Z-2168-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 192 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019041590 Exp: 6/30/2020

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.

device · product 9 of 13

DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Z-2169-2019

Recall number: Z-2169-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 1900 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019022690 Exp: 8/31/2020

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.

device · product 10 of 13

DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Z-2170-2019

Recall number: Z-2170-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 6180 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2018110590 Exp: 4/30/2020

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.

device · product 11 of 13

UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.

Z-2171-2019

Recall number: Z-2171-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 4560 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019012290 Exp: 7/31/2021

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.

device · product 12 of 13

LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.

Z-2172-2019

Recall number: Z-2172-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 3804 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019013190 Exp: 4/30/2021

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.

device · product 13 of 13

SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.

Z-2173-2019

Recall number: Z-2173-2019
Initiated: July 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Centurion Medical Products Corporation
Quantity: 48 each

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile packaging to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for sterile packaging to be compromised

Code information

Lot # 2019041290 Exp: 3/31/2024

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.