Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, ...
FDA Recall #Z-1119-2023 — Class II — December 7, 2022
Product Description
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;
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.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2753 units
Distribution
Nationwide
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.