CLASS II ONGOING Device recall · Reported 22 Feb 2023 · FDA Enforcement Report

Surgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LP

Medline Industries LP - Northfield is recalling Surgical convenience kits labeled as: a) Centurion Medical Products Chest Tube Insertion, distributed nationwide in the US. The recall was initiated on 7 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Reorder Number CVI2105, GTIN 40653160091546, Lot #22HMD248; b) Reorder Number MNS11975, GTIN 40653160325292, Lot #22HMD116; c) Reorder Number SUT11670, GTIN 40653160109762, Lot #22HMB913; d) Reorder Number SUT12060, GTIN 40653160120279, Lot #22HMC040; e) Reorder Number SUT14705, GTIN 40653160185438, Lot #22HMF267, 22HMF925; f) Reorder Number SUT17190, GTIN 40653160229231, Lot #22HMC041; g) Reorder Number SUT17195, GTIN 40653160229705, Lot #22HMH826; h) Reorder Number SUT17755, GTIN 40653160243701, Lot #22HMG491; i) Reorder Number SUT18475, GTIN 40653160258958, Lot #22HMH512; j) Reorder Number SUT19505, GTIN 40653160286166, Lot #22HMI064; k) Reorder Number SUT19620, GTIN 40653160289266, Lot #22HME946; l) Reorder Number SUT20205, GTIN 40653160293065, Lot #22IMA294; m) Reorder Number SUT20410, GTIN 40653160307052, Lot #22HME368; n) Reorder Number SUT21360, GTIN 40653160329436, Lot #22IMA124; o) Reorder Number SUT4655, GTIN 40653160015582, Lot #22HMC982; p) Reorder Number SUT5765, GTIN 40653160015865, Lot #22HMF927; q) Reorder Number UVT1075A, GTIN 10653160341956, Lot #22BBJ015; r) Reorder Number UVT505, GTIN 40653160182055, Lot #22FMF860; s) Reorder Number UVT835, GTIN 40653160289181, Lot #22GMF784
Quantity recalled2753 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1119-2023
FDA event ID
91483
Recalling firm
Medline Industries LP - Northfield, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
7 Dec 2022
FDA classified
10 Feb 2023
Reported
22 Feb 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

7 Dec 2022Recall initiated by company
10 Feb 2023Classified by FDA+65 days
22 Feb 2023Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT12060; e) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT14705; f) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17190; g) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17195; h) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT17755; i) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT18475; j) CENTURION MEDICAL PRODUCTS SUTURE SET, Reorder Number SUT19505; k) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT19620; l) CENTURION MEDICAL PRODUCTS UNITYPOINT HEALTH LACERATION T, Reorder Number SUT20205; m) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT20410; n) CENTURION MEDICAL PRODUCTS BASIC SUTURE TRAY, Reorder Number SUT21360; o) CENTURION MEDICAL PRODUCTS SUTURE PACK TRAY, Reorder Number SUT4655; p) CENTURION MEDICAL PRODUCTS SUTURING SET, Reorder Number SUT5765; q) CENTURION MEDICAL PRODUCTS UMBILICAL CATH INSERT TRAY, NO, Reorder Number UVT1075A; r) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL CATH INSERT T, Reorder Number UVT505; s) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL TRAY, Reorder Number UVT835;

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Which lots are affected?

a) Reorder Number CVI2105, GTIN 40653160091546, Lot #22HMD248; b) Reorder Number MNS11975, GTIN 40653160325292, Lot #22HMD116; c) Reorder Number SUT11670, GTIN 40653160109762, Lot #22HMB913; d) Reorder Number SUT12060, GTIN 40653160120279, Lot #22HMC040; e) Reorder Number SUT14705, GTIN 40653160185438, Lot #22HMF267, 22HMF925; f) Reorder Number SUT17190, GTIN 40653160229231, Lot #22HMC041; g) Reorder Number SUT17195, GTIN 40653160229705, Lot #22HMH826; h) Reorder Number SUT17755, GTIN 40653160243701, Lot #22HMG491; i) Reorder Number SUT18475, GTIN 40653160258958, Lot #22HMH512; j) Reorder Number SUT19505, GTIN 40653160286166, Lot #22HMI064; k) Reorder Number SUT19620, GTIN 40653160289266, Lot #22HME946; l) Reorder Number SUT20205, GTIN 40653160293065, Lot #22IMA294; m) Reorder Number SUT20410, GTIN 40653160307052, Lot #22HME368; n) Reorder Number SUT21360, GTIN 40653160329436, Lot #22IMA124; o) Reorder Number SUT4655, GTIN 40653160015582, Lot #22HMC982; p) Reorder Number SUT5765, GTIN 40653160015865, Lot #22HMF927; q) Reorder Number UVT1075A, GTIN 10653160341956, Lot #22BBJ015; r) Reorder Number UVT505, GTIN 40653160182055, Lot #22FMF860; s) Reorder Number UVT835, GTIN 40653160289181, Lot #22GMF784

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

19 other products · FDA event 91483

This product is part of a recall event; the main page for the event is Surgical convenience kits labeled as: Medline Arm/Minor Drape Cstm recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IISurgical convenience kits labeled as: Medline Arm/Minor Drape Cstm recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: Medline Breast Biopsy Kit recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: Medline Perf recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: Medline Prep Tray recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: Medline Cabg Pack recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: Medline Pain Tray recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: a) Medline General Utility recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: Medline Lcph Lab Draw Kit recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: a) Medline Hand Pack recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: Medline Plastics/Peds Kit recalledMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as recalled by MEDLINE INDUSTRIES, LPMedline Industries LP - NorthfieldSterilityNationwide
CLASS IISurgical convenience kits labeled as: a) Medline Perf recalledMedline Industries LP - NorthfieldSterilityNationwide

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