Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE...
FDA Device Recall #Z-3040-2024 — Class II — April 8, 2024
Recall Summary
| Recall Number | Z-3040-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
Product Description
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794; 6) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794H ; 7) CHEST TUBE INSERTION PACK , Pack Number DYNJ04474F ; 8) DRAINAGE FOR GRAPEVINE PACK , Pack Number DYNJ66222B ; 9) DRAINAGE PACK , Pack Number DYNJ67988A ; 10) CHEST/BREAST-LF , Pack Number DYNJ83950; 11) IR DRAIN PACK , Pack Number DYNJ85264; 12) INCISION AND DRAINAGE , Pack Number DYNJ904606C; 13) I&D TRAY, Pack Number MNS15250
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
CHT2120, Lot Number 23DLA374 ; CHT2120, Lot Number 23ELA871 ; CHT2120, Lot Number 23FLA655 ; DYNDA2475, Lot Number 22IMA813 ; DYNDA2941A , Lot Number 23BMB940 ; DYNDA2941A , Lot Number 23FMF503 ; DYNDA2998, Lot Number 22KBB005 ; DYNDA2998, Lot Number 23BBD525 ; DYNDH1794, Lot Number 22LBM374 ; DYNDH1794, Lot Number 23EBL615 ; DYNDH1794, Lot Number 23LMF847 ; DYNDH1794H , Lot Number 23LMF847 ; DYNDH1794H , Lot Number 22LBM374 ; DYNDH1794H , Lot Number 23EBL615 ; DYNJ04474F , Lot Number 22JLA750 ; DYNJ04474F , Lot Number 23BLA545 ; DYNJ04474F , Lot Number 23FLA171 ; DYNJ66222B , Lot Number 24ALA413 ; DYNJ66222B , Lot Number 24ALA509 ; DYNJ66222B , Lot Number 24CLA156 ; DYNJ67988A , Lot Number 22JMG867 ; DYNJ67988A , Lot Number 22LMI605 ; DYNJ67988A , Lot Number 23AMJ359 ; DYNJ67988A , Lot Number 23DMG616 ; DYNJ67988A , Lot Number 23EMI610 ; DYNJ67988A , Lot Number 23GMB085 ; DYNJ67988A , Lot Number 23IMH819 ; DYNJ67988A , Lot Number 23KMF739 ; DYNJ83950, Lot Number 23CBG610 ; DYNJ83950, Lot Number 23FBF248 ; DYNJ83950, Lot Number 23LBR075 ; DYNJ85264, Lot Number 23KBE782 ; DYNJ904606C, Lot Number 23HBP402 ; DYNJ904606C, Lot Number 23IBS124 ; DYNJ904606C, Lot Number 23JBN042 ; DYNJ904606C, Lot Number 23KBW145 ; MNS15250 , Lot Number 24AMC318
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
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.