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Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C...

FDA Device Recall #Z-3027-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-3027-2024
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) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Number DT19245; 6) BIOPSY KIT, Pack Number DYNDA1466A; 7) BIOPSY KIT, Pack Number DYNDA1466A; 8) CATH REMOVAL, Pack Number DYNDA1733B; 9) CATH REMOVAL, Pack Number DYNDA1814; 10) CATH REMOVAL, Pack Number DYNDA1814; 11) CATH REMOVAL, Pack Number DYNDA1814; 12) CATH REMOVAL, Pack Number DYNDA1814; 13) CATH REMOVAL, Pack Number DYNDA1814; 14) CATH REMOVAL, Pack Number DYNDA1814; 15) CATH REMOVAL, Pack Number DYNDA1814; 16) CATH REMOVAL, Pack Number DYNDA1814; 17) SHUNT TRAY, Pack Number DYNDA2725; 18) PORT ACCESS KIT, Pack Number DYNDC2945; 19) PORT ACCESS KIT, Pack Number DYNDC2945; 20) PORT ACCESS KIT, Pack Number DYNDC2945; 21) PORT ACCESS KIT, Pack Number DYNDC2945; 22) PORT ACCESS KIT, Pack Number DYNDC2945; 23) PORT ACCESS KIT, Pack Number DYNDC2945; 24) PORT ACCESS KIT, Pack Number DYNDC2945; 25) PORT ACCESS KIT, Pack Number DYNDC2945; 26) PORT ACCESS KIT, Pack Number DYNDC2945; 27) PORT ACCESS KIT, Pack Number DYNDC2945; 28) ARTHROGRAM TRAY, Pack Number DYNDH1113; 29) BIOPSY TRAY, Pack Number DYNDH1137C; 30) BIOPSY PACK, Pack Number DYNDH1248; 31) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 32) MYELOGRAM TRAY, Pack Number DYNDH1531; 33) BIOPSY PACK, Pack Number DYNDL1462B; 34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B; 36) PORT ACCESS TRAY, Pack Number EBSI1241; 37) PORT ACCESS TRAY, Pack Number EBSI1241; 38) PORT ACCESS TRAY, Pack Number EBSI1241; 39) PORT ACCESS TRAY, Pack Number EBSI1241; 40) PORT ACCESS TRAY, Pack Number EBSI1241; 41) PORT ACCESS TRAY, Pack Number EBSI1241; 42) PORT ACCESS TRAY, Pack Number EBSI1241; 43) PORT ACCESS TRAY, Pack Number EBSI1241; 44) PORT ACCESS TRAY, Pack Number EBSI1241; 45) PORT ACCESS TRAY, Pack Number EBSI1241; 46) PORT ACCESS TRAY, Pack Number EBSI1241; 47) PORT ACCESS TRAY, Pack Number EBSI1241; 48) PORT ACCESS TRAY, Pack Number EBSI1241; 49) PORT ACCESS TRAY, Pack Number EBSI1241; 50) PORT ACCESS TRAY, Pack Number EBSI1241; 51) PORT ACCESS TRAY, Pack Number EBSI1241; 52) PORT ACCESS TRAY, Pack Number EBSI1241; 53) PORT ACCESS TRAY, Pack Number EBSI1241; 54) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 55) DIALYSIS CHANGE KIT, Pack Number EBSI1453; 56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A; 58) OB DELIVERY TRAY, Pack Number MNS10875A; 59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 60) OB DELIVERY SET, Pack Number MNS3355; 61) LUMBAR TRAY, Pack Number SPEC0177; 62) 22G FACET TRAY, Pack Number SPEC0265A; 63) FINE LACERATION KIT, Pack Number SUT19360; 64) LACERATION TRAY, Pack Number SUT20955; 65) LACERATION TRAY, Pack Number SUT3780; 66) LACERATION TRAY, Pack Number SUT3780; 67) SUTURING SET, Pack Number SUT4020

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

ART245C, Lot Number 2023083090; CHT1900, Lot Number 2020092590; CHT560, Lot Number 2020110590; CHT705, Lot Number 2023011790; DT19245 , Lot Number 21JBN311 ; DYNDA1466A, Lot Number 2021111090; DYNDA1466A, Lot Number 2023091890; DYNDA1733B, Lot Number 2019021950; DYNDA1814, Lot Number 2018103050; DYNDA1814, Lot Number 2018121450; DYNDA1814, Lot Number 2019010950; DYNDA1814, Lot Number 2019021950; DYNDA1814, Lot Number 2019041850; DYNDA1814, Lot Number 2019112250; DYNDA1814, Lot Number 2020031350; DYNDA1814, Lot Number 2020100801; DYNDA2725, Lot Number 2023011790; DYNDC2945, Lot Number 2020071090; DYNDC2945, Lot Number 2020090990; DYNDC2945, Lot Number 2020110590; DYNDC2945, Lot Number 2020122890; DYNDC2945, Lot Number 2021081890; DYNDC2945, Lot Number 2021120890; DYNDC2945, Lot Number 2022121290; DYNDC2945, Lot Number 2023011090; DYNDC2945, Lot Number 2023080790; DYNDC2945, Lot Number 2023091890; DYNDH1113, Lot Number 2020031350; DYNDH1137C, Lot Number 2021011890; DYNDH1248, Lot Number 2019021950; DYNDH1359, Lot Number 2023080790; DYNDH1531, Lot Number 2022020990; DYNDL1462B, Lot Number 2019010950; EBSI1039B, Lot Number 2023083090; EBSI1039B, Lot Number 2023110390; EBSI1241, Lot Number 2019120590; EBSI1241, Lot Number 2020040390; EBSI1241, Lot Number 2020061990; EBSI1241, Lot Number 2020092590; EBSI1241, Lot Number 2020111390; EBSI1241, Lot Number 2021011890; EBSI1241, Lot Number 2021041290; EBSI1241, Lot Number 2021091590; EBSI1241, Lot Number 2021111090; EBSI1241, Lot Number 2021120690; EBSI1241, Lot Number 2022020990; EBSI1241, Lot Number 2022042290; EBSI1241, Lot Number 2022072690; EBSI1241, Lot Number 2022082990; EBSI1241, Lot Number 2022101390; EBSI1241, Lot Number 2023011790; EBSI1241, Lot Number 2023090690; EBSI1241, Lot Number 2023110390; EBSI1453, Lot Number 2022022180; EBSI1453, Lot Number 2022032880; EBSI1453A, Lot Number 2022093090; EBSI1453A, Lot Number 2023083090; MNS10875A, Lot Number 2023011790; MNS12150, Lot Number 2022121290; MNS3355, Lot Number 2020071090; SPEC0177, Lot Number 2019120590; SPEC0265A, Lot Number 2019120590; SUT19360, Lot Number 2022042290; SUT20955, Lot Number 2020092590; SUT3780, Lot Number 2020061990; SUT3780, Lot Number 2020111390; SUT4020, Lot Number 2023091890

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

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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.

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