Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, ...
FDA Device Recall #Z-1119-2023 — Class II — December 7, 2022
Recall Summary
| Recall Number | Z-1119-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 7, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 2753 units |
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.
Distribution Pattern
Nationwide
Lot / 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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.