Z-1119-2023Class II

Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number...

Name: Z-1119-2023 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-12-07
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-12-07 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY... on 2022-12-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1119-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-07
Posted: 2023-02-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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;
Product code: LRP Tray, Surgical
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, LP." "If you have any questions, please contact the Recall Department at 866-359-1704."
Quantity in commerce: 2753 units
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1119-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1110-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1111-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1112-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1113-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1114-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1115-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1116-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1117-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1118-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1119-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1120-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1121-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1122-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1123-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1124-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1125-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1126-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1127-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1128-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10

Product code LRP

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)