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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Centurion Medical Products Corporation: Potential for sterile packaging to be compromised

Agency Publication Date: August 6, 2019
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Affected Products

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.

Lot # 2019041790 Exp 3/31/2024 Lot # 2019030490 Exp 2/29/2024

Lot Numbers:
2019041790
2019030490
Product: 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.

Lot # 2019020590 Exp : 8/31/2020

Lot Numbers:
2019020590
Product: CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.

Lot # 2019052190 Exp : 9/30/2021

Lot Numbers:
2019052190
Product: CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.

Lot # 2019051390 Exp: 8/31/2021

Lot Numbers:
2019051390
Product: NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.

Lot # 2019043090 Exp: 8/31/2020

Lot Numbers:
2019043090
Product: LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.

Lot # 2019031190 Exp: 06/30/2020

Lot Numbers:
2019031190
Product: DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Lot # 2019052190 Exp: 4/30/2021

Lot Numbers:
2019052190
Product: HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Lot # 2019041590 Exp: 6/30/2020

Lot Numbers:
2019041590
Product: DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Lot # 2019022690 Exp: 8/31/2020

Lot Numbers:
2019022690
Product: DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Lot # 2018110590 Exp: 4/30/2020

Lot Numbers:
2018110590
Product: UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.

Lot # 2019012290 Exp: 7/31/2021

Lot Numbers:
2019012290
Product: LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.

Lot # 2019013190 Exp: 4/30/2021

Lot Numbers:
2019013190
Product: SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.

Lot # 2019041290 Exp: 3/31/2024

Lot Numbers:
2019041290

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83329
Status: Resolved
Manufacturer: Centurion Medical Products Corporation
Manufactured In: United States
Units Affected: 13 products (From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each; 400 each; 220 each; 168 each; 120 each; 1224 each; 3250 each; 192 each; 1900 each; 6180 each; 4560 each; 3804 each; 48 each)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.